Novartis receives EC label update approval for Cosentyx in ankylosing spondylitis

pharmafile | October 24, 2019 | News story | Research and Development  

Novartis has announced that the European Commission has approved a label update for the up-titration of Cosentyx (secukunumab) to 300mg for patients with active ankylosing spondylitis.

The approval comes on the back of data from Novartis’ three year MEASURE 3 trial that explored the tolerability and efficacy of Cosentyx in patients with ankylosing spondylitis.

The results found that response rates were greater in the 300mg dose group particularly amongst patients with previous anti-TNF exposure. This is contrast to the recommended dose of 150mg. Furthermore the safety profile remained consistent with previous studies.

Global Head of Medical Affairs of Immunology, Hepatology and Dermatology at Novartis, Sam Khalil, said: “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 ankylosing spondylitis.”

Cosentyx is the first and only fully-human biologic that directly inhibits interleukin 17A, a corner cytokine directly involved in the inflammation and development of psoriatic arthritis, psoriasis, and ankylosing spondylitis.

The drug is backed by robust clinical evidence, including 5 year data across the aforementioned conditions. More than 250,000 patients have been treated with the drug since its launch in January 2015.

Nik Kiran

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