Novartis’ Cosentyx (Secukinumab) Approved by European Commission for Two Subtypes of Juvenile Idiopathic Arthritis

Image Source: Shutterstock

News on June 30, 2022 /BioValleyBIOON/ -- Novartis recently announced that the European Commission (EC) has approvedAnti-inflammatory Drug Cosentyx (Chinese Brand Name: Keshanting, Generic Name: Secukinumab, Commonly Known as "Sukinumab"): As monotherapy or in combination with methotrexate, used for pediatric patients aged ≥6 years who have an inadequate response to or are intolerant of conventional therapy, to treat two types of juvenile idiopathic arthritis (JIA) – Enthesitis-related Arthritis (ERA) and Juvenile Psoriatic Arthritis (JPsA).Cosentyx will provide a much-needed effective treatment option for underserved ERA and JPsA patient populations in Europe.

In the United States, Cosentyx was approved in December 2021: (1) for the treatment of patients aged 4 years and older with active ERA; (2) for the treatment of patients aged 2 years and older with active JPsA. Data from the Phase 3 JUNIPERA study show,In pediatric patients with ERA and JPsA, during two years of treatment, Cosentyx reduced the risk of disease flares and improved disease activity compared to placebo, with a safety profile consistent with the known safety characteristics of the drug.

Since its initial approval in 2015, Cosentyx has demonstrated sustained efficacy in the treatment of various systemic inflammatory diseases and has been used to treat more than 700,000 patients worldwide.

Juvenile Idiopathic Arthritis (JIA) is the most commonChildrenRheumatic Diseases, affecting millions of children worldwide. Unfortunately, due to the limited current or available treatment options, some patients continue to experience symptoms.ERA and JPsA are subtypes of JIA, belonging to autoimmune diseases.ImmunitySexually transmitted diseases.ERA is characterized by joint swelling and pain, with tendons and ligaments attaching to bones, and may present with lower back pain or tenderness upon hip palpation. JPsA is characterized by joint swelling and psoriasis, with possible nail changes, dactylitis, or psoriatic skin changes in first-degree relatives (FDR).If not treated in time, ERA and JPsA may lead to severe pain and disability.

Todd Fox, Global Head of Medical Affairs Immunology at Novartis, stated: "Cosentyx can now provide options for those still struggling with joint inflammation, swelling in fingers and toes, etc.Quality of LifeProvides a treatment option for patients struggling with pain symptoms that have a negative impact. This approval marks an important step forward in our goal of expanding Cosentyx to treat 10 indications across rheumatologic and dermatologic conditions in both children and adults."

This EU approval is based on data from the Phase 3 JUNIPERA study. This was a two-year, three-part, double-blind, placebo-controlled, randomized withdrawal trial that enrolled 86 children and adolescents aged 2-18 with ERA or JPsA. The primary endpoint of the study was the time to flare during Treatment Period 2 (Week 12 to Week 104).

The results showed that the study met the primary endpoint:During treatment period 2, compared with placebo, the time to onset of ERA and JPsA flares was longer in patients treated with Cosentyx.StatisticsSignificantly delayed in learningSpecifically, during treatment period 2, compared with the placebo group, the Cosentyx group...The risk of recurrence was significantly reduced by 72% (HR=0.28; 95%CI:0.13-0.63; p＜0.001).During the placebo-controlled treatment period of the study, a total of 21 patients in the placebo group experienced disease flare events (11 cases of JPsA and 10 cases of ERA), compared to 10 patients in the Cosentyx group (4 cases of JPsA and 6 cases of ERA). The safety profile of Cosentyx in this pediatric population was consistent with its safety profile in treating plaque psoriasis (PsO), PsA, axial spondyloarthritis (axSpA) in both adult and pediatric patients.

Cosentyx is the first fully human monoclonal antibody drug that specifically targets and inhibits interleukin-17A (IL-17A)., which can selectively target and block the activity of circulating IL-17A, reduce immune system activity, and improve disease symptoms. Studies have shown that IL-17A plays a key role in driving the immune response in various autoimmune diseases, including psoriatic arthritis (PsA), plaque psoriasis (PsO), ankylosing spondylitis (AS), and non-radiographic axial spondyloarthritis (nr-axSpA).

Cosentyx was approved for marketing in January 2015 and has currently been approved for five indications (PsO [≥6 years], PsA [≥2 years], AS [≥18 years], nr-axSpA [≥18 years], ERA [≥4 years]).Cosentyx is a proven drug with over 14 years of clinical research. It is supported by strong clinical evidence, including five-year adult clinical data demonstrating the long-term safety and efficacy of the drug in treating PsO, PsA, AS, and nr-axSpA. These data reinforce Cosentyx's therapeutic position across AS, axSpA, PsA, and PsO. Since its launch in 2015, more than 700,000 patients worldwide have been treated with Cosentyx.

In China, Cosentyx has been approved for two indications (PsO [≥6 years], AS [≥18 years]). Currently, Novartis is conducting an extensive clinical program with the goal of expanding Cosentyx's indications to 10 within the next decade. (Bioon.com)

Source of the original text:Cosentyx (secukinumab) receives expanded approvals in EU for use in childhood arthritic conditions