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EU approval for Novartis' Cosentyx in active non-radiographic axial spondyloarthritis

Published on 29/04/20 at 10:28am

Novartis has revealed that the European Commission has moved to approve Cosentyx (secukinumab) for the treatment of active non-radiographic axial spondyloarthritis (nr-axSpA) in adult patients.

The authorisation was awarded after Phase 3 data drawn from the largest-ever study of a biologic drug in nr-axSpA showed that Cosentyx met its primary endpoint in trials investigating its efficacy in treating the condition.

An estimated 1.7 million patients live with nr-axSpA across the US and the top five EU countries.

The data revealed that 41.5% of patients receiving the drug saw a “significant and clinically meaningful” reduction in disease activity, as measured by an improvement of at least 40% on the Assessment in Ankylosing Spondylitis response criteria (ASAS40), compared to 29.2% with placebo. These reductions were maintained through 52 weeks of treatment.

The study also showed that Novartis’ therapy showed “significant improvements” in its secondary endpoints of disease burden, pain, and health-related quality of life.

“Whether a patient has nr-axSpA or AS, the condition has a significant impact on their everyday life. We therefore welcome the news that Cosentyx has gained approval for the treatment of this form of axial spondyloarthritis because it enables patients to realize relief from their symptoms earlier in the spectrum of disease,” said Eric Hughes, Global Development Unit Head, Immunology, Hepatology & Dermatology at Novartis. “This is a firm demonstration of our commitment to reimagine medicine for patients and a step forward in our plans to expand Cosentyx across ten indications over the next ten years.”

Matt Fellows

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