Data demonstrates that secukinumab shows a significantly longer time to flare versus placebo
Novartis has announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for Cosentyx – also known as secukinumab.
It involves the therapy being provided alone or with methotrexate (MTX), in two types of juvenile idiopathic arthritis (JIA) – enthesitis-related arthritis (ERA) or juvenile psoriatic arthritis (JPsA). The treatment is used among patients of six years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapies.
This approval is based on results from the phase 3 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 placebo.
Furthermore, the risk of flare was reduced by 72% for patients on secukinumab for two years, while more patients achieved and maintained JIA American College of Rheumatology (ACR) score 30, 50, 70, 90 and 100 with secukinumab, compared with placebo at two years.
“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,” explained Marie-Andrée Gamache, country president at 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,” she added.
JIA is the most common type of arthritis in under 16 year olds, affecting around one in 1,000 with approximately 1,500 diagnosed across 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, these debilitating conditions can lead to high levels of pain, joint swelling and disability, with many young people continuing to have active disease well into adulthood. If properly managed, however, it is possible for patients to live with inactive disease and prevent the progression of rheumatoid arthritis, which can include hand, limb and spine deformities.
An extension study of secukinumab, evaluating the long-term efficacy, safety and tolerability for four years in patients with ERA and JPsA is ongoing.