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Novartis Gets Approval For Cosentyx Label Update In Europe - Quick Facts

(RTTNews) - Swiss drug major Novartis AG (NVS) said it has received approval for Cosentyx label update in Europe to include dosing flexibility in ankylosing spondylitis (AS).

According to Novartis, the European Commission or EC has approved a label update for the up-titration of Cosentyx, or secukinumab, to 300 mg for patients with active ankylosing spondylitis.

The approval is based on data from MEASURE 3, a three-year Phase III study that explored the tolerability and efficacy of Cosentyx in patients with AS.

In the study, response rates were greater in the 300 mg dose group, particularly among patients with previous anti-TNF exposure, compared with the recommended 150 mg dose. The safety profile was consistent with previous studies.

"This approval gives rheumatologists more flexibility to ensure their patients are able to achieve the best response to treatment. It further encourages our ongoing efforts to reimagine care to ensure all patients are able to experience full relief from the signs and symptoms of AS," said Sam Khalil, Global Head of Medical Affairs Immunology, Hepatology and Dermatology at Novartis.

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