Novartis receives FDA nod for new indication of Cosentyx
Novartis has secured the Food and Drug Administration’s blessing for Cosentyx (secukinumab) for the treatment of active enthesitis-related arthritis in four years and older, and active juvenile psoriatic arthritis 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 United States. These are the second and third approvals for Cosentyx in a pediatric population in the United States, and Cosentyx now has a total of five indications acdrug stote news pooss rheumatology and dermatology.
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“Prior research suggests that despite receiving treatment, some children and adolescents with PsA or ERA can continue to experience symptoms,” said Hermine Brunner, 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.”
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“This marks the second and third U.S. 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.
Fox continued, “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.”