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Novartis: Cosentyx Gets EU Approval To Treat Adult Patients With Active Nr-axSpA

Swiss drug major Novartis (NVS) announced Wednesday the European Commission has approved Cosentyx (secukinumab) for the treatment of adult patients with active non-radiographic axial spondyloarthritis or nr-axSpA.

Cosentyx is the first fully-human IL-17A inhibitor indicated for patients in Europe with nr-axSpA, which forms part of the axial spondyloarthritis or axSpA disease spectrum. The company noted that there are approximately 1.7 million patients with nr-axSpA in the top five EU countries and US.

Cosentyx is also approved for the treatment of moderate-to-severe plaque psoriasis, psoriatic arthritis and ankylosing spondylitis.

The company said the approval underlines Cosentyx leadership in rheumatology and immuno-dermatology, with plans to expand to 10 indications over the next 10 years.

The approval is based on data from the Phase III PREVENT study, in which Cosentyx met the primary endpoint. Statistically significant improvements in secondary endpoints were also demonstrated, including pain, disease burden and health-related quality of life.

Novartis said it is working closely with all stakeholders to ensure that eligible European patients can start benefitting from Cosentyx as quickly as possible.

Novartis has also submitted Cosentyx for review by the US Food and Drug Administration and the Japan Pharmaceuticals and Medical Devices Agency for the treatment of adults with nr-axSpA.

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