dm+d
34952011000001109
Refrigerated Storage
DupixentSanofi
Sanofi
Dupixent
Solution for injection in pre-filled syinge
In the event of an inadvertent temperature excursion the following data may be used:
If necessary, pre-filled syringes may be kept at room temperature up to 25°C for a maximum of 14 days. Do not store above 25°C. If the carton needs to be removed permanently from refrigerator, the date of removal may be recorded on the outer carton. After removal from the refrigerator, Dupixent must be used within 14 days or discarded.
Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk
Please contact Sanofi for products exposed to conditions other than described above. Refer to current BNF for company contact details.
See above.
See above.
Do not freeze.
Store in the original carton in order to protect from light.
12 October 2020
London MI Service
New Medicines
DupixentNasal polyposis and chronic sinusitis in adults
Information
Dupixent
Licence extension / variation
Sanofi
Regeneron
Development and Regulatory status
Launched
Launched
Launched
October 2019
Oct 19Approved in the EU [14].
Sep 19Recommended for EU approval by CHMP - the additional indication is "Chronic rhinosinusitis with nasal polyposis (CRSwNP). Dupixent is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adults with severe CRSwNP for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control.” [12].
Jun 19Approved in US [10].
May 19Filed in EU [11].
Mar 19FDA has granted priority review and set a decision date of June 26th 2019 [9].
Mar 19Filed in US for the treatment for inadequately controlled severe chronic rhinosinusitis with nasal polyps (CRSwNP) [8].
Mar 18Filings planned for 2019 [6].
Sep 16PIII trial expected to start Q1 17 [4].
Category
An anti-interleukin-4 receptor (IL-4R) and anti-interleukin-13 receptor (IL-13R) human monoclonal antibody
The population prevalence of nasal polyps is reported as 2-4%, with no racial predilection. The male to female ratio has been reported at approximately 2:1 [1].
Nasal polyposis and chronic sinusitis in adults
Subcutaneous
Further information
Yes
Suspended
Trial or other data
Sep 19Results of PIII LIBERTY NP SINUS-24 (NCT02912468) and LIBERTY NP SINUS-52 (NCT02898454) are published; the studies (total n=724) found dupilumab significantly reduced nasal polyp size vs. placebo (−2.06; 95% CI −2.43 to −1.69, p<0.0001 in SINUS-24 and −1.80; 95% CI −2.10 to −1.51, p<0.0001 in SINUS-52) and improved sinus opacification & severity of symptoms [13].
Oct 18Sanofi and Regeneron announce topline results from two PIII studies of dupilumab in adults with inadequately-controlled chronic rhinosinusitis with nasal polyps (CRSwNP). At 24 weeks, patients who had dupilumab added to a SOC corticosteroid nasal spray experienced a 51% and 57% improvement in nasal congestion/obstruction severity (co-primary endpoints) vs. 15% and 19% improvement with nasal spray alone [7].
Dec 16Two PIII RCT comparing dupilumab every other week vs placebo in patients with bilateral nasal polyposis already on intranasal corticosteroids have started. NCT02912468 (n=240) is a 24-week study due to complete Jul18 and NCT02898454 (n=360) is a 52-week study due to complete Dec 18 [5].
Feb 16Results of a PII, double-blind RCT (NCT01920893) published in JAMA. 60 patients received dupilumab or placebo loading dose (x2) followed by weekly dose through subcutaneous (SC) injection in combination with mometasone furoate nasal spray for 16 weeks. Primary outcome measure: Change in endoscopic nasal polyp score (range, 0-8; higher scores indicate worse status). 51 patients completed the study. The least squares (LS) mean change in nasal polyp score was −0.3 (95% CI, −1.0 to 0.4) with placebo and −1.9 (95% CI, −2.5 to −1.2) with dupilumab (LS mean difference, −1.6 [95% CI, −2.4 to −0.7]; P < .001). The LS mean difference between the 2 groups for the Lund-Mackay CT total score was −8.8 (95% CI, −11.1 to −6.6; P < .001). Significant improvements with dupilumab were also observed for the 22-item SinoNasal Outcome Test (LS mean difference between groups, −18.1 [95% CI, −25.6 to −10.6]; P < .001) and sense of smell assessed by UPSIT (LS mean difference, 14.8 [95% CI, 10.9 to 18.7]; P < .001). The most common adverse events were nasopharyngitis (33% in the placebo group vs 47% in the dupilumab group), injection site reactions (7% vs 40%, respectively), and headache (17% vs 20%) [2,3].
12/05/2016 13:08:43
Evidence based evaluations
DupixentModerate to severe atopic dermatitis in children aged ≥12 to 17 years who are inadequately controlled with topical therapies
Information
Dupixent
Licence extension / variation
Sanofi
Regeneron
Development and Regulatory status
Launched
Launched
Launched
August 2019
Aug 19The EU has extended the marketing authorization for Dupixent® (dupilumab) to include adolescents 12 to 17 years of age with moderate-to-severe atopic dermatitis [10].
Jun 19Recommended for EU approval by CHMP - the amended indication is "for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy." [9].
Mar 19Approved in US for treatment of moderate-to-severe atopic dermatitis in adolescents aged 12 to 17 years whose disease is not adequately controlled with topical prescription therapies or when these therapies are contra-indicated [9].
Jan 19Granted EAMS status in UK for treatment of adolescent patients between 12 and 18 years of age with severe atopic dermatitis for whom the available systemic therapies are not suitable [8].
Nov 18Granted priority review in the US [6].
Sep 18Q3 Also filed in the EU for children with atopic dermatitis aged 12 to 17 years [7].
Mar 18Filings planned for 2018 [3].
Oct 16FDA grants breakthrough therapy status for dupilumab for treatment of moderate to severe atopic dermatitis in children aged 12 to less than 18 years of age, who are not adequately controlled with, or who are intolerant to, topical medication [4].
Category
Anti-interleukin-4 receptor (IL-4R) and anti-interleukin-13 receptor (IL-13R) human monoclonal antibody
Atopic eczema is common and the prevalence is increasing. Eczema affects 15-20% of school children and 2-10% of adults [1].
Moderate to severe atopic dermatitis in children aged ≥12 to 17 years who are inadequately controlled with topical therapies
Subcutaneous
Trial or other data
Nov 19Results of NCT03054428 RCT (n=251) are published; it found dupilumab 200 or 300 mg every 2 weeks and 300 mg every 4 weeks significantly improved signs, symptoms, and quality of life in adolescents with moderate to severe atopic dermatitis vs placebo, following 16-week treatment, with an acceptable safety profile [11].
Sep 18PIII study results found co-primary endpoint of EASI-75 at 16 weeks met by 41.5% of patients who received Dupixent every two weeks and 38% of patients who received Dupixent every four weeks compared to 8% with placebo (p less than 0.001). IGA results (US patients) were 24%, 18% and 2% respectively [5].
Dec 17Recruitment has finished in PIII study (NCT03054428) [2].
Apr 17PIII trial to investigate the efficacy and safety of dupilumab as a monotherapy in children aged 12 to 18 years, with moderate-to-severe atopic dermatitis starts (NCT03054428). 240 patients will be enrolled in the US & Canada. primary outcomes are Proportion of patients with Investigator Global Assessment (IGA) 0 to 1 (on a 5-point scale) (For US and ex-US) at week 16, and proportion of patients with Eczema Area and Severity (EASI) EASI-75 (≥75% improvement from baseline) (For ex-US) at week 16. Collection of these data is due to complete May 18 [2].
Evidence based evaluations
DupixentModerate to severe atopic dermatitis in adults who are candidates for systemic therapy, with or without topical therapy
Information
Dupixent
New molecular entity
Sanofi
Regeneron
Development and Regulatory status
Launched
Launched
Launched
December 2017
Aug 19New 200mg/1.14ml soln for inj in pre-filled syringe strength available, 2=£1264.89 [26].
Dec 17Launched in UK. Price for 300mg/2ml soln for inj in pre-filled syringe, 2=£1264.89 [25].
Sep 17Approved in EU [24].
Jul 17Following an earlier-than-expected backing from the EMA, Sanofi expects to launch Dupixent in Germany, its first EU market, by year´s end [21].
Jul 17EU CHMP recommends approval for treatment of moderate-to-severe atopic dermatitis in adult patients who are candidates for systemic therapy [20].
May 17Sanofi and Regeneron report successful launch in the US and high initial prescribing rates (estimated 3,500 prescriptions by May 4th) despite the high list price of $37,000 per year (net price will be lower) [19].
Mar 17Sanofi / Regeneron announce that the FDA has approved dupilumab for marketing in the US; they expect the drug to be available to patients and providers within a week of the announcement [17].
Mar 17Awarded EAMS status in the UK for use in adults with severe atopic dermatitis who have failed to respond, or who are intolerant of or ineligible for all approved therapies. Dupilumab can be used with or without topical corticosteroids [16].
Dec 16Filed in EU [14].
Sep 16Filed in US, and granted priority review, with a PDUFA date of March 29 2017 [12].
Jun 16Regeneron & Sanofi expect potential approval and subsequent US launch in early 2017 [11].
Apr 16Sanofi intend to file in the US, based on results from SOLO 1 and SOLO 2 trials, in the third quarter of 2016 [10].
Nov 14Dupilumab gets FDA Breakthrough Therapy Designation based on positive results from PI and PII trials.
Category
Anti-interleukin-4 receptor (IL-4R) and anti-interleukin-13 receptor (IL-13R) human monoclonal antibody
Atopic eczema is common and the prevalence is increasing. Eczema affects 15-20% of school children and 2-10% of adults [3].
Moderate to severe atopic dermatitis in adults who are candidates for systemic therapy, with or without topical therapy
Subcutaneous
Further information
Yes
August 2018
Trial or other data
Apr 18Draft guidance from NICE does not recommend dupilumab since cost-effective estimates are higher than those NICE normally considers an acceptable use of NHS resources. Consultation is open until 24th Apr 18 and final guidance is due Aug 18 [26].
Sep 17Positive results from the PIII CAFE trial (n=325) were presented at the European Academy of Dermatology and Venereology (EADV) Congress. In the study, dupilumab with topical corticosteroids (TCS) significantly improved measures of overall disease severity, skin clearing, itching, and patient reported quality of life measures. 59% of patients who received dupilumab weekly with TCS, and 63% of patients who received dupilumab every two weeks with TCS achieved EASI-75, compared to 30% of patients who received placebo with TCS (p<0.0001). No new adverse events were reported in the study [23].
May 17Results of PIII LIBERTY AD CHRONOS trial published in The Lancet. RCT (n=740) reported that dupilumab added to standard topical corticosteroid treatment for one year improved atopic dermatitis lesions, vs placebo, in patients with moderate-to-severe atopic dermatitis [18].
Mar 17Sanofi and Regeneron announce detailed results from the one-year Phase 3 CHRONOS study. At 16 weeks, the mean percent improvement in EASI from baseline was 77 percent for patients who received Dupixent weekly with TCS and for patients who received Dupixent every two weeks with TCS, compared to 42 percent for patients receiving placebo with TCS (p less than 0.0001). At 16 weeks, the mean percent improvement from baseline in the intensity of patient-reported itch, as measured by the Pruritus Numerical Rating Scale (NRS), was 55 percent for patients who received Dupixent weekly with TCS and 58 percent for patients who received Dupixent every two weeks with TCS, compared to 29 percent for patients receiving placebo with TCS (p less than 0.0001). At 16 weeks, 77 percent of patients who received Dupixent weekly with TCS or Dupixent every two weeks with TCS achieved a >=4-point improvement in the severity of their AD, as measured by the Patient Oriented Eczema Measure (POEM), a tool that quantifies the illness as experienced by the patients, compared to 37 percent of patients receiving placebo with TCS (p less than 0.0001). At 16 weeks, 74 percent of patients who received Dupixent weekly with TCS and 81 percent of patients who received Dupixent every two weeks with TCS achieved a >=4-point improvement in aspects of their quality of life, as measured by the Dermatology Life Quality Index (DLQI), compared to 43 percent of patients receiving placebo with TCS (p less than 0.0001). Dermatology life Quality Index (DLQI) is a ten-question questionnaire used to measure the impact of skin disease on the quality of life of an affected person. At 52 weeks, the mean percent improvement in EASI from baseline was 80 percent for patients who received DUPIXENT weekly with TCS and 78 percent for patients who received DUPIXENT every two weeks with TCS, compared to 46 percent for patients receiving placebo with TCS (p less than 0.0001). At 52 weeks, the mean percent improvement from baseline in the intensity of patient-reported itch, as measured by the NRS, was 54 percent for patients who received DUPIXENT weekly with TCS and 56 percent for patients who received DUPIXENT every two weeks with TCS, compared to 27 percent for patients receiving placebo with TCS (p less than 0.0001). At 52 weeks, 64 percent of patients who received Dupixent weekly with TCS and 76 percent of patients who received Dupixent every two weeks with TCS achieved a >=4-point improvement in the severity of their AD, as measured by POEM, compared to 26 percent of patients receiving placebo with TCS (p less than 0.0001). At 52 weeks, 63 percent of patients who received Dupixent weekly with TCS and 80 percent of patients who received Dupixent every two weeks with TCS achieved a >=4-point improvement their quality of life, as measured by the DLQI, compared to 30 percent of patients receiving placebo with TCS (p less than 0.0001) [15].
Mar 17Regeneron Pharmaceuticals completed the PIII CAFE trial, that investigated the efficacy, safety and tolerability of dupilumab in patients with severe atopic dermatitis, who are inadequately controlled with or are intolerant to oral ciclosporin, or when this treatment is not medically advisable (NCT02755649; EudraCT2015-002653-35). The primary endpoint was the proportion of patients with EASI 75 (≥ 75% improvement from baseline) at week 16. The double-blind, parallel, randomised, placebo-controlled trial was initiated in Nov 2015 and enrolled 325 patients in across Europe including the UK [22].
Oct 16Results of SOLO 1 (NCT02277743) and SOLO 2 (NCT02277769) published in NEJM. The two identical RCTs (n=671 and 708) found significantly more patients with dupilumab achieved primary outcome (proportion of patients with score of 0/1 (clear/almost clear) on Investigator’s Global Assessment and reduction of ≥2 points from baseline at week 16) vs. placebo (p<0.00) [13].
Jun 16Long-term PIII data announced. Dupilumab combined with topical corticosteroids--the standard of care--beat SoC alone at 16 and 52 weeks. Four out of 10 patients on the drug demonstrated a complete or near complete clearing of skin lesions, with 64% achieving a 75% elimination of eczema [11].
Apr 16Sanofi announce that in SOLO 1 and SOLO 2, between 30-40% of patients who received dupilumab (300mg weekly or every 2 weeks), an inhibitor of IL-4 and IL-13, achieved clearing or near-clearing of skin lesions, vs., 10 and 8.5% on placebo in the two studies [10].
Oct 15Regeneron Pharmaceuticals initiate a phase III trial (EudraCT2015-001396-40) to assess the long-term safety and efficacy of dupilumab in children and adolescents (6 years to 18 years) with atopic dermatitis [9].
Mar 15PIII (NCT02395133) study to assess the ability of different dupilumab dose regimens, administered as monotherapy, to maintain treatment response achieved after 16 weeks of initial treatment with dupilumab monotherapy compared to placebo starts. 440 pts will be enrolled by invitation. It is expected to complete collection of primary outcome data (Proportion of patients with Investigator´s Global Assessment (IGA) scores of 0 or 1 [clear or almost clear] at week 36) in Jul 16 [8].
Oct 14PIII studies of dupilumab in pts with Atopic Dermatitis begin. LIBERTY AD CHRONOS is a randomized, double-blind, placebo-controlled, multi-national study with the primary objective of demonstrating the efficacy of dupilumab in adults with moderate to severe AD when administered concomitantly with topical corticosteroids through 16 weeks. Secondary objectives of the study will evaluate the long-term safety and efficacy of dupilumab up to 52 weeks. The trial will enroll approximately 700 adults. The estimated primary completion date is end of 2015 [5,6].
Jul 14Sanofi and Regeneron announce positive PIIb data showing all five SC doses of dupilumab showed an improvement in the primary endpoint, mean percent change in Eczema Area and Severity Index (EASI) score from baseline to week 16. These ranged from a high of 74% for patients on 300mg weekly to a low of 45% for those on 100mg monthly; this compares with 18% for all doses for patients in the placebo group. Data from two PIIa trials and two PI studies published in the New England Journal of Medicine. The data showed that the drug as monotherapy or in combination with topical glucocorticoids improved skin lesions and itching [4].
Apr 14Open-label PIII extension trial (R668-AD-1225 trial) for patients with moderate-to severe atopic dermatitis who have previously participated in controlled trials of dupilumab (NCT01949311) will assess long-term safety and efficacy, and the primary endpoint of number of treatment-emergent adverse events will be assessed at weeks 52 and 116 [2].
Nov 13NCT01859988 is a randomized, double-blind, placebo-controlled, dose-ranging PII study investigating the efficacy, safety, pharmacokinetic and biomarker profiles of dupilumab administered to 240 adult patients with moderate-to-severe atopic dermatitis. The primary outcome is % change in Eczema Area and Severity Index score from baseline to week 16. The study starts May 13 and is due to complete Jul 14 [1].
13/11/2013 16:09:27
Oct 13NCT01949311 is an open-label PIII study of dupilumab in 800 patients with atopic dermatitis who participated in previous dupilumab clinical trials. The primary outcome is the incidence and rate (events per patient-year) of treatment-emergent adverse events at week 52 and week 116. The study starts Oct 13 and is due to complete Oct 16 [1].
Evidence based evaluations
DupixentAsthma, uncontrolled, persistent in adults and adolescents aged 12 years and over - add-on therapy
Information
Dupixent
Licence extension / variation
Sanofi
Regeneron
Development and Regulatory status
Launched
Launched
Launched
May 2019
May 19Licensed for patients >12yrs as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or FeNO, who are inadequately controlled with high dose ICS+another medicinal product for maintenance treatment [19].
May 19Approved in EU [18].
Feb 19Recommended for EU approval by CHMP - the additional indication is "Asthma. Dupixent is indicated in adults and adolescents 12 years and older as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised FeNO (see section 5.1), who are inadequately controlled with high dose ICS plus another medicinal product for maintenance treatment." [17].
Oct 18FDA has approved Dupixent® (dupilumab) as an add-on maintenance therapy in patients with moderate-to-severe asthma aged 12 years and older with an eosinophilic phenotype or with oral corticosteroid-dependent asthma [16].
Apr 18Filed in EU [13].
Dec 17Filed in the US for persistent, uncontrolled asthma [12].
Sep 17EU filing planned for Q1 18 [11].
Mar 17US filing planned for Q4 17 [9].
Dec 16NCT02414854 (Liberty Asthma Quest) still due to complete Nov17; the long-term safety study (NCT02134028, Liberty asthma traverse) is due to complete Oct19 [7].
Dec 15NCT02414854 (Liberty Asthma Quest) is now recruiting in EU and UK [5].
May 15PIII study begins. The antibody is already in PIII for its primary indication of eczema, and now Regeneron has launched a 1,600-patient pivotal trial in asthma, testing two doses of dupilumab. After meeting with the FDA, Regeneron now believes the agency will recognize an earlier PIIb asthma study as one of two required pivotal trials [3].
Category
Anti-interleukin-4 receptor (IL-4R) and anti-interleukin-13 receptor (IL-13R) human monoclonal antibody
There were over 79,800 emergency hospital admissions for asthma in the UK in 2008/09. Of these, 30,740 were children aged 14 years or under. There were 1,131 deaths from asthma in the UK in 2009 (12 were children aged 14 years or under). An estimated 75% of admissions for asthma are avoidable and as many as 90% of the deaths from asthma are thought to be preventable.
Asthma, uncontrolled, persistent in adults and adolescents aged 12 years and over - add-on therapy
Subcutaneous
Further information
Yes
To be confirmed
Trial or other data
May 18Results of PIII LIBERTY ASTHMA QUEST (NCT02414854) published in NEJM [15].
May 18Results of PIII LIBERTY ASTHMA VENTURE (NCT02528214, n=210) published in NEJM. Dupilumab reduced oral glucocorticoid use (−70.1% glucocorticoid dose dupilumab group vs. −41.9% placebo; p<0.001), decreased rate of severe exacerbations and increased FEV1. Transient eosinophilia was seen in ~ 1 in 7 dupilumab treated patients [14].
Sep 17Positive results from the pivotal PIII LIBERTY ASTHMA QUEST (NCT02414854; n=1,902) trial have been reported, with dupilumab meeting both primary endpoints. Dupilumab reduced the frequency of severe asthma attacks by 46% in the group overall, and by 60% to 67% in patients with high levels of eosinophilic cells [10].
Jun 17Q2 Regeneron Pharmaceuticals and Sanofi plan to initiate the PIII Liberty Asthma Voyage trial to assess the efficacy, safety and tolerability of dupilumab SC in children (aged 6 to < 12 years) with uncontrolled persistent asthma (EFC14153; EudraCT2016-001607-23; NCT02948959). The randomised, double-blind, parallel, placebo-controlled trial will enrol approximately 294 patients in the US [8,9].
Apr 16Results of PIIb dose-ranging trial (NCT01854047) published online in the Lancet. This RCT (n=769) found that dupilumab increased lung function and reduced severe exacerbations in patients with uncontrolled persistent asthma irrespective of baseline eosinophil count vs. placebo. Dupilumab was found to have a favourable safety profile [6].
Apr 15PIII (NCT02414854) study begins recruitment in the US. Primary outcomes are annualised rate of severe exacerbation events at 52 weeks & absolute change from baseline in pre-bronchodilator forced expiratory volume in one second (FEV1). Collection of this data should complete in Aug 17 [4].
Nov 14Positive PIIb data reported. In the study, which enrolled 776 adults with moderate-to-severe uncontrolled asthma, dupilumab showed a reduction in the annual rate rate of severe exacerbations vs. placebo by 64% to 75%. The data revealed dupilumab's effectiveness in a broad study population. Based on these results, Sanofi & Regeneron plan to move dupilumab into PIII [2].
Evidence based evaluations
DupixentSevere atopic dermatitis in children aged ≥6 to 11 years who are inadequately controlled with topical therapies
Information
Dupixent
Licence extension / variation
Sanofi
Regeneron
Development and Regulatory status
Launched
Launched
Launched
November 2020
Nov 20Licence change to include use in children aged 6 to 11 years approved in EU [13].
Oct 20Recommended for EU approval by CHMP - the additional indication is "Children 6 to 11 years of age: Dupixent is indicated for the treatment of severe atopic dermatitis in children 6 to 11 years old who are candidates for systemic therapy" [12].
Aug 20Granted EAMS status by the MHRA for treatment of children aged 6 to 11 years with severe atopic dermatitis (allergic eczema) that is not controlled by medicines applied as creams or ointments to the skin [11].
May 20Approved in US [10].
Feb 20Has also been filed in the EU [9].
Jan 20The FDA has accepted for Priority Review the supplemental Biologics License Application for dupilumab as an add-on maintenance treatment for children aged 6 to 11 years with moderate-to-severe atopic dermatitis [8].
Nov 19Expected submission is now 2019 [7].
Mar 19Filings planned for 2019 [3].
Feb 19Filings will now be 2020 [5].
Oct 16FDA grants breakthrough therapy status for dupilumab for treatment of severe atopic dermatitis in children aged 6 months to less than 12 years of age, who are not adequately controlled with, or who are intolerant to, topical medication [4].
Category
Anti-interleukin-4 receptor (IL-4R) and anti-interleukin-13 receptor (IL-13R) human monoclonal antibody
Atopic eczema is common and the prevalence is increasing. Eczema affects 15-20% of school children and 2-10% of adults [1].
Severe atopic dermatitis in children aged ≥6 to 11 years who are inadequately controlled with topical therapies
Subcutaneous
Trial or other data
Aug 19Topline data for the PIII study found that 70% patients given dupilumab 300 mg every 4 weeks, and 67% given dupilumab 100 mg or 200 mg every 2 weeks achieved a 75% or greater skin improvement (EASI-75) vs 27% for placebo (p<0.0001 for both) [6].
Dec 17PIII trial to evaluate the efficacy of dupilumab in paediatric patients (6-11 year-olds) for the treatment of atopic dermatitis starts (NCT03345914). The trial is enrolling approximately 240 patients in the US. Primary outcome is proportion of patients with Investigator´s Global Assessment (IGA) 0 or 1 (on a 5-point scale) at week 16 Collection of these data is due to complete Jan 19 [2].
Evidence based evaluations
DupixentUncontrolled persistent asthma in children aged 6 to 11 years
Information
Dupixent
Licence extension / variation
Sanofi
Regeneron
Development and Regulatory status
None
Phase III Clinical Trials
Pre-registration (Filed)
Feb 21FDA accepts sBLA for review [5].
Oct 20US and EU regulatory submissions for children aged 6-11 years planned by Q1 2021. [4]
Oct 19Filings will now be in 2021 [3].
Filings planned for 2022 at the earliest [1].
Category
Anti-interleukin-4 receptor (IL-4R) and anti-interleukin-13 receptor (IL-13R) human monoclonal antibody
There were over 79,800 emergency hospital admissions for asthma in the UK in 2008/09. Of these, 30,740 were children aged 14 years or under. There were 1,131 deaths from asthma in the UK in 2009 (12 were children aged 14 years or under). An estimated 75% of admissions for asthma are avoidable and as many as 90% of the deaths from asthma are thought to be preventable.
Uncontrolled persistent asthma in children aged 6 to 11 years
Subcutaneous
Trial or other data
Oct 20Data from the PIII LIBERTY ASTHMA VOYAGE randomised, double-blind, placebo-controlled trial (n=408 children aged 6 to 12 years. Injection site reactions, viral upper respiratory tract infections and eosinophilia were most common adverse effects. [4]
Jun 18PIII Liberty Asthma Excursion trial to evaluate the long-term safety and tolerability of dupilumab SC in children, aged 7 to 12 years with asthma who completed the treatment in the Liberty Asthma Voyage trial starts (NCT03560466). The open-label, single group assignment trial will enrol approximately 236 patients in the US [2].
Mar 17PIII Liberty Asthma Voyage trial to assess the efficacy, safety and tolerability of dupilumab SC in children, aged 6 to 11 years, with uncontrolled persistent asthma starts (NCT02948959). The randomised trial will enrol 471 patients in the US and other countries including the EU (not UK). Primary outcome is annualised rate of severe exacerbation events during the placebo-controlled treatment period; collection of these data is due to complete Jul 21 [2].
DupixentSevere atopic dermatitis in children aged ≥6 months to 5 years who are inadequately controlled with topical therapies
Information
Dupixent
Licence extension / variation
Sanofi
Regeneron
Development and Regulatory status
Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials
Category
Anti-interleukin-4 receptor (IL-4R) and anti-interleukin-13 receptor (IL-13R) human monoclonal antibody
Atopic eczema is common and the prevalence is increasing. It is seen in 20% of children in developed countries and in developing countries the prevalence is heading towards this figure. The large majority (about 80%) of cases present before the age of 5 years [1].
Severe atopic dermatitis in children aged ≥6 months to 5 years who are inadequately controlled with topical therapies
Subcutaneous
Eosinophilic oesophagitis in adults and adolescents
Information
Licence extension / variation
Sanofi
Regeneron
Development and Regulatory status
None
None
Phase III Clinical Trials
Yes
Category
Anti-interleukin-4 receptor (IL-4R) and anti-interleukin-13 receptor (IL-13R) human monoclonal antibody
Eosinophilic esophagitis (EoE) is a chronic, allergic disease of the esophagus characterized clinically by symptoms of esophageal dysfunction (including vomiting, dysphagia, feeding disorders, food impaction and abdominal pain) which persist after treatment with proton pump inhibitors (PPIs). The current prevalence is estimated at 1/2,300-1/1,750 worldwide and appears to be on the increase. It is a predominantly male disorder [1].
Eosinophilic oesophagitis in adults and adolescents
Subcutaneous injection
DupixentModerate to severe chronic obstructive pulmonary disease (COPD) with type 2 inflammation
Information
Dupixent
Licence extension / variation
Sanofi Genzyme
Regeneron
Development and Regulatory status
None
Phase III Clinical Trials
Phase III Clinical Trials
Category
Human monoclonal antibody that inhibits interleukin-4 (IL-4) and interleukin-13 (IL-13) signalling. IL-4 and IL-13 are major drivers of human type 2 inflammatory disease [1,2]
In the UK, it is estimated that more than 3 million people currently have COPD, with the disease being undiagnosed in about 2 million of these. Most people are not diagnosed until they are ≥50 years old. Prevalence of COPD increases with age and varies significantly by region. A GP practice in the UK which cares for about 7000 people will have up to 200 people with COPD on its practice list . This equates to about 1.4 million consultations with GPs each year in the UK [3]
Moderate to severe chronic obstructive pulmonary disease (COPD) with type 2 inflammation
Subcutaneous injection
DupixentPrurigo nodularis (PN) in adults
Information
Dupixent
Licence extension / variation
Sanofi Genzyme
Regeneron
Development and Regulatory status
None
Phase III Clinical Trials
Phase III Clinical Trials
Category
Anti-interleukin-4 receptor (IL-4R) and anti-interleukin-13 receptor (IL-13R) human monoclonal antibody
The condition appears to be relatively common, particularly among patients who have some of the associated/precipitating conditions (infections, acute kidney injury, psychiatric conditions, malignancies); however, there are no surveys of its prevalence in the general population. It is more common in middle-aged women [1].
Prurigo nodularis (PN) in adults
Subcutaneous injection
DupixentChronic spontaneous urticaria in adolescents and adults who remain symptomatic despite the use of H1 antihistamines and who are naïve to, intolerant of, or incomplete responders to omalizumab
Information
Dupixent
Licence extension / variation
Sanofi Genzyme
Regeneron
Development and Regulatory status
None
None
Phase III Clinical Trials
Category
Anti-interleukin-4 receptor (IL-4R) and anti-interleukin-13 receptor (IL-13R) human monoclonal antibody
Approximately 15% of people experience urticaria at some time in their lives. Acute urticaria is much more common than chronic urticaria. (Estimated lifetime incidence is 1 in 6 people compared to 1 in 1,000.) The prevalence rate for chronic urticaria has been estimated as 1-5 per 1,000 [1].
Chronic spontaneous urticaria in adolescents and adults who remain symptomatic despite the use of H1 antihistamines and who are naïve to, intolerant of, or incomplete responders to omalizumab
Subcutaneous injection
DupixentBullous pemphigoid
Information
Dupixent
Licence extension / variation
Sanofi Genzyme
Regeneron
Development and Regulatory status
None
None
Phase III Clinical Trials
Category
Anti-interleukin-4 receptor (IL-4R) and anti-interleukin-13 receptor (IL-13R) human monoclonal antibody
The incidence of pemphigoid in the UK is estimated at 4.3 per 100,000 persons per year. In other parts of Europe the incidence is 0.7-1.3 per 100,000. It is the most commonly seen autoimmune blistering disease [1].
Bullous pemphigoid
Subcutaneous injection