Cosentyx gets FDA approval for juvenile psoriatic arthritis

[Fred]

Cosentyx (secukinumab) has been approved by the Food and Drug Administration (FDA) for use in juvenile psoriatic arthritis (JPsA)

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Novartis, today announced the US Food and Drug Administration (FDA) has approved Cosentyx® (secukinumab) for the treatment of active enthesitis-related arthritis (ERA) in four years and older, and active juvenile psoriatic arthritis (JPsA) in patients two years and older. Cosentyx is now the first biologic indicated for ERA, and the only biologic treatment approved for both ERA and PsA in pediatric patients in the US. These are the second and third approvals for Cosentyx in a pediatric population in the US, and Cosentyx now has a total of five indications across rheumatology and dermatology.

“Prior research suggests that despite receiving treatment, some children and adolescents with PsA or ERA can continue to experience symptoms,” said Hermine Brunner, M.D., Cincinnati Children’s Hospital. “The findings from the Phase III JUNIPERA trial show that pediatric patients treated with secukinumab demonstrated marked responses throughout the treatment period. This approval is positive news for some patients who continue to struggle with painful symptoms like inflammation of the joints and swollen fingers and toes.”

ERA and JPsA, subtypes of juvenile idiopathic arthritis (JIA), are autoimmune diseases. ERA is characterized by joint swelling and pain where tendons and ligaments attach to bone and may present with low back pain or tenderness at the palpation of the hips. JPsA is characterized by joint swelling and skin psoriasis and may present with nail changes, inflammation of fingers and/or toes or psoriatic skin changes in a first-degree relative. If left untreated, they can lead to high levels of pain and disability.

“This marks the second and third US pediatric approval this year for Cosentyx, following pediatric psoriasis approval and further reinforces the proven efficacy and safety of the therapy. With more than 500,000 adult and pediatric patients treated worldwide since launch, healthcare professionals and patients can feel confident in Cosentyx,” said Todd Fox, Global Head of Medical Affairs Immunology, Hepatology and Dermatology at Novartis. “Furthermore, we are pleased to build on our strong heritage of bringing innovative treatments to young people living with rheumatic diseases, which began with the FDA approval of Ilaris. We are committed to bringing Cosentyx to this pediatric community globally as part of our ambition to expand Cosentyx to 10 indications in areas of high unmet need.”

The approved pediatric dosing for Cosentyx in children and adolescents is 75 mg (15 kg or more to less than 50 kg) or 150 mg (50 kg or more). It is administered as a subcutaneous injection by a pre-filled syringe or Sensoready® pen every 4 weeks after initial loading doses. With appropriate guidance/instruction from a healthcare professional, Cosentyx can be administered by an adult caregiver outside of a healthcare provider’s office via a single-dose prefilled syringe or Sensoready® pen.

The approval is based on data from the Phase III JUNIPERA study, a two-year, three-part, double-blind, placebo-controlled, randomized-withdrawal trial that enrolled 86 children and adolescents aged 2 to 18 years old with a confirmed diagnosis of ERA or JPsA according to a modified International League of Associations for Rheumatology classification criteria. The primary endpoint of the study was time to flare in the treatment period 2 (Week 12 to Week 104). In children and adolescents aged 2 to 18 years old, the study demonstrated that patients with active JPsA (n = 34; mean age: 12.) treated with Cosentyx had a longer time to flare, showing an 85% reduction in the risk of flare (P<0.001) versus placebo. The study also demonstrated that patients with active ERA (n = 52; mean age: 13.7) treated with Cosentyx had a significantly longer time to flare, showing a 53% reduction in the risk of flare versus placebo. Safety in this pediatric population was consistent with the known safety profile of Cosentyx for the treatment of plaque psoriasis, PsA, non-radiographic axial spondyloarthritis and ankylosing spondylitis.

Source: novartis.com

Cosentyx (secukinumab)