UK MHRA expands Cosentyx® (secukinumab) licence for use in paediatric arthritic conditions

• Cosentyx^® (secukinumab) has received UK marketing authorisation for the treatment of enthesitis-related arthritis (ERA) and juvenile psoriatic arthritis (JPsA) in patients 6 years and older¹
• Authorisation is based on data showing that secukinumab demonstrated a significantly longer time to flare versus placebo in paediatric patients with ERA and JPsA²
• ERA and JPsA are forms of juvenile idiopathic arthritis (JIA), a progressive and debilitating autoimmune condition that is the most common type of arthritis in young people, with around 1,500 new diagnoses in the UK every year^3,4
• Secukinumab is the first interleukin inhibitor indicated specifically for ERA and JPsA in paediatric patients in the UK, offering them a treatment option that can be administered less frequently¹

London, November 7, 2022 — Novartis today announced that the UK Medicines & Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for Cosentyx^® (secukinumab), alone or in combination with methotrexate (MTX), in two types of juvenile idiopathic arthritis (JIA), enthesitis-related arthritis (ERA) and juvenile psoriatic arthritis (JPsA), in patients 6 years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy¹.

JIA is the most common type of arthritis in under 16s, affecting about 1 in 1,000 with approximately 1,500 diagnosed in the UK every year^3,4. ERA and JPsA are forms of JIA and are progressive, debilitating autoimmune diseases, each accounting for up to 11% of all JIA cases^3-6. If left untreated, they can lead to high levels of pain, joint swelling and disability, with many young people continuing to have active disease well into adulthood^4-7. But if properly managed, it’s possible for patients to live with inactive disease and prevent the progression of rheumatoid arthritis, including hand, limb and spine deformities⁴.

“We are pleased to announce the news of marketing authorisation for secukinumab in young people living with ERA and JpsA and are delighted that they will now have the possibility of accessing an additional treatment option,” said Marie-Andrée Gamache, Country President, Novartis Innovative Medicines UK and Ireland. “At Novartis, we are continuing in our aspiration to eliminate the disease burden for every person living with painful and debilitating long-term immunological conditions by leading in the commercial sponsorship of clinical trials and turbo-charging discovery with investments in data and digital technologies.” 

This approval is based on results from the Phase III JUNIPERA trial, which showed significantly longer time to flare for both JPsA and ERA patients who were treated with secukinumab compared with those given the placebo². The risk of flare was reduced by 72% for patients on secukinumab for 2 years compared with patients on placebo². Additionally, more patients achieved and maintained JIA American College of Rheumatology (ACR) score 30, 50, 70, 90 and 100 with secukinumab compared with placebo at 2 years¹.

“If left untreated, both ERA and JPsA can lead to high levels of pain and long-term disability. Evidence shows secukinumab reduces flare risk and joint symptoms in young people affected by JPsA and ERA for a sustained period up to 2 years. This authorisation provides us with an alternative targeted therapy, offering patients the potential for a monthly dosing option,” said Professor Athimalaipet Ramanan, consultant paediatric rheumatologist at University Hospitals Bristol and Weston NHS Foundation Trust (UHBW).

Safety in this paediatric population was consistent with the known safety profile of secukinumab for the treatment of adult and paediatric plaque psoriasis, PsA and axial spondyloarthritis⁸. An extension study of secukinumab evaluating the long-term efficacy, safety and tolerability up to 4 years in patients with ERA and JPsA is currently ongoing⁹.

About the JUNIPERA trial

The Phase III JUNIPERA trial is a 2-year, three-part, double-blind, placebo-controlled, randomised withdrawal trial that enrolled 86 children and adolescents aged 2–18 years old with a confirmed diagnosis of ERA or JPsA according to the modified International League of Associations for Rheumatology classification criteria¹⁰. The trial met its primary endpoint and demonstrated a statistically significant longer time to disease flare in treatment period 2 for ERA and JPsA with secukinumab versus placebo. A total of 21 patients in the placebo group experienced a flare (11 JPsA and 10 ERA) compared with 10 patients in the secukinumab group (4 JPsA and 6 ERA) during the placebo-controlled treatment period 2 of the trial². Safety in this paediatric population was consistent with the known safety profile of secukinumab for the treatment of adult and paediatric plaque psoriasis, PsA and axial spondyloarthritis².

About Cosentyx

Cosentyx is the first and only fully human biologic that directly inhibits interleukin-17A, an important cytokine involved in the inflammation of PsA, moderate to severe plaque psoriasis, paediatric plaque psoriasis, paediatric ERA, JPsA, ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA)^11,12. Cosentyx is a proven medicine and has been studied clinically for more than 14 years. The medicine is backed by robust evidence, including 5 years of clinical data in adults supporting long-term safety and efficacy in adult patients with moderate to severe plaque psoriasis, PsA, AS and nr-axSpA^13-19. These data strengthen the position of Cosentyx as a treatment option in these conditions, and are supported by more than 875,000 patients treated worldwide since launch in 2015^{12, 20, 21}.

About Novartis

Novartis is reimagining medicine to improve and extend people’s lives. As a leading global medicines company, we strive to use innovative science and digital technologies to create treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world’s top companies investing in research and development. Novartis products reach more than 800 million people globally and we are finding innovative ways to expand access to our latest treatments. About 108,000 people of more than 140 nationalities work at Novartis around the world.

In the UK, we employ approximately 1,500 people to serve healthcare needs across the whole of the UK, as well as supporting the global operations of Novartis. Since 2014, Novartis has invested over £200 million in R&D and is a leading sponsor of clinical trials in the UK. For more information, please visit www.novartis.co.uk.

Novartis UK is on Twitter. Sign up to follow @NovartisUK at www.twitter.com/novartisuk

References

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