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

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
Pre-registration (Filed)
Launched
Oct 21Approved in US [8].
Apr 21Also filed in the EU. In US seeking an indication for 6 to 11-yr-olds with uncontrolled moderate to severe asthma, and in the EU seeking an indication for 6 to 11-yr-olds with uncontrolled severe asthma [7].
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].
Jul 18Filings 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

May 21Manufacturers report positive results for PIII VOYAGE trial (n=408); dupilumab reduced date of severe asthma attacks vs placebo in children with asthma aged 6 to 11 years by between 65% and 59% over one year [6].
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].

Evidence based evaluations

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 patients 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

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
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 patients 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

Dupixent Chronic sinusitis without nasal polyps

Information

Dupixent
Licence extension / variation
Sanofi Genzyme
Regeneron

Development and Regulatory status

None
Phase III Clinical Trials
Phase III Clinical Trials

Category

An anti-interleukin-4 receptor (IL-4R) and anti-interleukin-13 receptor (IL-13R) human monoclonal antibody
Chronic sinusitis is a common condition, affecting 1 in 10 UK adults. Data suggest a prevalence of 4.5-12% in North American and European populations. Its prevalence increases with age, and it is more likely to occur in women, and in people with asthma, chronic obstructive pulmonary disease, or a history of allergy [1].
Chronic sinusitis without nasal polyps
Subcutaneous injection

DupixentPrimary acquired chronic inducible cold urticaria (ColdU) in patients aged 12 years and older

Information

Dupixent
Licence extension / variation
Sanofi
Regeneron

Development and Regulatory status

None
Phase III Clinical Trials
Phase III Clinical Trials

Category

Monoclonal antibody that inhibits interleukin-4 (IL-4) and interleukin-13 (IL-13) signalling by specifically binding to the IL-4Rα subunit shared by the IL-4 and IL-13 receptor complexes
Acquired cold urticaria is rare and the exact number of people that have it is unknown. The incidence in central Europe is thought to be 0.05%. It usually affects young adults, but can appear at any age. It is twice as common in females than males. Cold urticaria usually lasts for some years. About 30% report resolution of symptoms within 5 to 10 years. A 20-year follow-up study of 41 patients diagnosed with cold urticaria showed it had resolved by 10 years in about a quarter of patients [2,3].
Primary acquired chronic inducible cold urticaria (ColdU) in patients aged 12 years and older
Subcutaneous injection