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Novartis’ Cosentyx receives MHRA approval for two types of juvenile idiopathic arthritis

A phase 3 trial showed significantly longer time to flare for both JPsA and ERA patients

Novartis

Novartis’ Cosentyx (secukinumab) has been approved by the UK Medicines Medicines & Healthcare products Regulatory Agency (MHRA) for the treatment of two types of juvenile idiopathic arthritis (JIA) in patients aged six years and older.

Specifically, the interleukin-17A inhibitor may be used alone or in combination with methotrexate in patients with enthesitis-related arthritis (ERA) and juvenile psoriatic arthritis (JPsA), whose disease has responded inadequately to, or who cannot tolerate, conventional therapy.

JIA is the most common type of arthritis in patients aged under 16 years, with approximately 1,500 diagnosed in the UK every year. ERA and JPsA are forms of JIA and are progressive, autoimmune diseases, each accounting for up to 11% of all JIA cases.

If left untreated, they can lead to high levels of pain, joint swelling and disability, with many young patients continuing to have active disease into adulthood. However, if properly managed, it is possible for patients to live with inactive disease and prevent the progression of rheumatoid arthritis.

The MHRA’s decision is based on results from the phase 3 JUNIPERA trial, which demonstrated significantly longer time to flare for both JPsA and ERA patients who were treated with Cosentyx compared with those given the placebo.

The risk of flare was reduced by 72% for patients on Cosentyx for two years compared with patients on placebo. Additionally, more patients achieved and maintained JIA American College of Rheumatology score 30, 50, 70, 90 and 100 with secukinumab compared with placebo at two years.

Safety in this paediatric population was consistent with the known safety profile of Cosentyx for the treatment of adult and paediatric plaque psoriasis, PsA and axial spondyloarthritis, the company reported.

Novartis also outlined that an extension study of Cosentyx evaluating the long-term efficacy, safety and tolerability up to four years in patients with ERA and JPsA is currently ongoing.

“If left untreated, both ERA and JPsA can lead to high levels of pain and long-term disability… 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.

Also commenting on the approval, Marie-Andrée Gamache, country president, Novartis Innovative Medicines UK and Ireland, said: “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.”

Article by
Emily Kimber

10th November 2022

From: Research, Regulatory

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