dm+d

29215811000001103

Refrigerated Storage

CosentyxNovartis Pharmaceuticals

Novartis Pharmaceuticals
Cosentyx
Solution for injection in pre-filled pen or syringe

In the event of an inadvertent temperature excursion the following data may be used:

If necessary, Cosentyx may be stored unrefrigerated for a single period of up to 4 days at room temperature, not above 30°C.

Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk.

26 January 2022
London MI Service

New Medicines

CosentyxModerate to severe chronic plaque psoriasis in children and adolescents aged 6-17 years old - plus new 75mg injection formulation

Information

Cosentyx
Licence extension / variation and new formulation
Novartis
Novartis

Development and Regulatory status

Launched
Launched
Launched
August 2020
Jul 2175mg injection formulation available in the UK [11].
Jul 21MHRA approves a 75mg injection formulation of Cosentyx in a pre-filled syringe, licensed for treatment of moderate to severe plaque psoriasis in children and adolescents from the age of 6 years who are candidates for systemic therapy. Previously only 150mg and 300mg pre-filled syringes and pens were licensed [10].
Jun 21US FDA approve secukinumab for children >6 years with moderate-to-severe plaque psoriasis.[9]
Oct 20Filed in US [8].
Aug 20Approved in EU [7]
Jun 20Recommended for EU approval by CHMP - the additional indication is "for the treatment of moderate to severe plaque psoriasis in children and adolescents from the age of 6 years who are candidates for systemic therapy [6].
Mar 20Currently pre-registration in EU. Has been filed using the centralised procedure [5].

Category

Interleukin-17A antagonist
It is estimated that approximately 30–50 % of adults with psoriasis developed psoriasis before 20 years of age [1]. A worldwide systematic review found that the prevalence of psoriasis in children ranged from 0% to 1.37% [2].
Moderate to severe chronic plaque psoriasis in children and adolescents aged 6-17 years old - plus new 75mg injection formulation
Subcutaneous injection

Further information

Yes

Trial or other data

Nov 19PIII study (NCT02471144) has completed; final data was collected Dec 2018 [4].
Jun 18PIII study (NCT02471144) is still recruiting [3].
Sep 15PIII study (NCT02471144) to assess efficacy and safety of secukinumab versus placebo at Week 12, based on both PASI 75 and IGA mod 2011 0 or 1 response rates in children and adolescents aged 6 to less than 18 years with severe chronic plaque psoriasis who had inadequate control of symptoms with topical treatment, or failed to respond to or tolerate previous systemic treatment and/or UV therapy. 160 patients will be recruited from sites including the US and EU (incl. UK). Collection of primary outcome data is due to complete Nov 19 [3].

Evidence based evaluations

CosentyxPsoriatic arthritis - axial manifestations

Information

Cosentyx
Licence extension / variation
Novartis
Novartis

Development and Regulatory status

Launched
Launched
Phase III Clinical Trials
June 2021
Jun 21MHRA approves use of Cosentyx to treat axial manifestations of PsA. The SPC update includes data from the PIIIb MAXIMISE trial [5].
Mar 21EU approves use of Cosentyx to treat axial manifestations of PsA. The label update includes data from the PIIIb MAXIMISE trial [4].

Category

Fully human IgG1k anti-IL17A antibody
Prevalence of psoriatic arthritis varies from 20-420 per 100,000 population across the world. In about 80% of cases the presence of psoriasis precedes the onset of psoriatic arthritis [2].
Psoriatic arthritis - axial manifestations
Subcutaneous injection

Trial or other data

Jun 20Results from PIII MAXIMISE trial published on US trial registry [3].
Jun 19Novartis announce PIII MAXIMISE trial (NCT02721966) meets both primary and key secondary endpoints with 63.1% of secukinumab 300 mg and 66.3% of secukinumab 150 mg patients achieving ASAS20 at week 12 (vs 31.3% for placebo), respectively [1].

Information

Cosentyx
Licence extension / variation
Novartis
Novartis

Development and Regulatory status

Phase III Clinical Trials
Launched
Launched
Jun 22Licence extension approved in EU [12].
May 22Recommended for EU approval by CHMP – the extension to the existing indication is for “use alone or in combination with methotrexate for the treatment of active enthesitis-related arthritis in patients 6 years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy, and for the treatment of active juvenile psoriatic arthritis in patients 6 years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy“ [11].
Dec 21FDA approves secukinumab for the treatment of active enthesitis-related arthritis (ERA) in patients four years and older and active psoriatic arthritis (PsA) in patients two years and older [10]
Aug 21Has also been filed in the US [9].
Aug 21Pre-registration in the EU [7,8].
Feb 21Novartis pipeline lists the planned filing date as 2021 [5].

Category

Interleukin-17A antagonist
Juvenile idiopathic arthritis has an annual incidence of 0.1 per 1,000 children in the UK (equivalent to 1,000 children diagnosed per year). Polyarthritis accounts for about 25% of new diagnosis [1].
Juvenile idiopathic arthritis including enthesitis-related arthritis (ERA) and juvenile psoriatic arthritis in patients aged 2 to 18 years
Subcutaneous injection

Further information

Yes

Trial or other data

Jun 21Novartis presents positive topline PIII results from JUNIPERA study (NCT03031782) which met its primary endpoint, with secukinumab showing significantly longer time to flare (or worsening of symptoms) vs. placebo (P<.001) in pediatric patients with two subtypes of juvenile idiopathic arthritis (children with JIA). More pts achieved and maintained the JIA American College of Rheumatology (ACR) 30 and JIA ACR 70 responses from Week 12 to Week 104 vs. placebo. The safety profile was favorable with no new safety signals reported over 2 years of treatment.[6]
Feb 21PIII study (NCT03031782) completed in October 2020 [4]; results are awaited.
Jan 20PIII study (NCT03031782) is active but no longer recruiting. Primary completion date 22Oct19 [3].
Sep 18PIII study (NCT03031782) is still recruiting [2].
May 17PIII trial to evaluate the efficacy and safety of secukinumab in paediatric patients with juvenile idiopathic arthritis (JIA), including subtypes of juvenile psoriatic arthritis and enthesitis-related arthritis starts (NCT03031782). The study is divided into 3 parts consisting of open-label, single-arm active treatment in the first and third treatment period, and a randomised, double-blind, placebo controlled, event-driven withdrawal design in the second treatment period. 80 children and adolescent patients will be recruited in the US, Belgium, Germany, Italy, Poland, Russia, Spain, South Africa, Turkey and the UK. Collection of primary outcome data (time to flare in treatment period 2 from Week 12 until max Week 104) is due to complete Nov 19 [2].

Evidence based evaluations

CosentyxModerate to severe hidradenitis suppurativa in adults with an inadequate response to conventional systemic HS therapy

Information

Cosentyx
Licence extension / variation
Novartis
Novartis

Development and Regulatory status

Phase III Clinical Trials
Pre-registration (Filed)
Phase III Clinical Trials
Sep 22Company expects to submit data to the FDA before the end of 2022 [9]
Jul 22Currently pre-registration in EU [8].
Oct 19Filings planned 2022 [3].

Category

Interleukin-17A antagonist
Hidradenitis suppurativa is a chronic persistent or recurrent suppurative disease of unknown cause occurring in the apocrine follicles, usually affecting the groin and axillae and also other apocrine-bearing sites such as the breasts, perineum and buttocks. Prevalence in Europe has been estimated to be in the region of 1% [1].
Moderate to severe hidradenitis suppurativa in adults with an inadequate response to conventional systemic HS therapy
Subcutaneous injection

Further information

Yes

Trial or other data

Sep 22Company reports mixed results from PIII SUNSHINE and SUNRISE trials. A significantly higher proportion of pts achieved a Hidradenitis Suppurativa Clinical Response (HiSCR) when receiving Cosentyx 300mg every two weeks after a standard weekly loading dosage vs placebo at week 16 in both studies. The same dosage every four weeks after standard weekly loading doses demonstrated superiority to placebo for HiSCR in the SUNRISE study but missed statistical significance in SUNSHINE [9]
Feb 22PIII (NCT04179175) is recruiting 745 patients with moderate to severe HS completing either of the core trials (SUNSHINE and SUNRISE). It will assess proportion with HiSCR, with data expected 2025 [7].
Jan 22PIII SUNSHINE and SUNRISE trials still ongoing, primary data not yet published [6].
Jan 21Primary completion date for both PIII SUNSHINE and PIII SUNRISE trials is now October 2021 [5].
Nov 19PIII SUNSHINE and SUNRISE trials are both still recruiting. the estimated primary completion date for SUNSHINE is now March 2021; SUNRISE is still July 2021 [4].
Feb 19PIII SUNRISE trial to assess the safety, tolerability, and superiority of subcutaneously administered secukinumab at week 16 vs. placebo, along with the maintenance of efficacy of secukinumab at week 52, in patients with moderate to severe hidradenitis suppurativa starts (NCT03713632). 471 patients will be recruited in the US, Belgium, Denmark, Lithuania, Greece, Germany, Hungary, Spain, and the UK. Primary outcome is proportion of patients with a 50% HS clinical response (HiSCR) rates; collection of these data is due to complete Jul 21 [2].
Jan 19PIII SUNSHINE trial to assess the safety, tolerability, and superiority of subcutaneously administered secukinumab at week 16 vs. placebo, along with the maintenance of efficacy of secukinumab at week 52, in patients with moderate to severe hidradenitis suppurativa starts (NCT03713619). 471 patients will be recruited from sites including the US, Australia, Japan, Russia, Belgium, Germany, Hungary, Spain, and the UK. Primary outcome is proportion of patients with a 50% HS clinical response (HiSCR) rates; collection of these data is due to complete Jun 21 [2].

Evidence based evaluations

CosentyxLupus nephritis in adults

Information

Cosentyx
Licence extension / variation
Novartis
Novartis

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials

Category

A fully human IgG1/κ monoclonal antibody that selectively binds to and neutralises the proinflammatory cytokine interleukin-17A (IL-17A).
Systemic lupus eryethamatosus (SLE) affected nearly 1 in 1,000 of the population in 2012 in the UK. The age-standardised incidence in the UK is 8.3 per 100,000/year for females and 1.4 per 100,000/year for males in the UK. About one third of SLE patients develop lupus nephritis in the UK [1].
Lupus nephritis in adults
Subcutaneous injection