Latest approval for Novartis’ Cosentyx, from US FDA

Adding to recent marketing clearances in Japan and the European Union, the US Food and Drug Administration yesterday approved Swiss pharma giant Novartis’ (NOVN: VX) Cosentyx (secukinumab) for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy (a drug that is absorbed into the bloodstream and distributed to all parts of the body) or phototherapy (light therapy).

Cosentyx is the first approved psoriasis medication to selectively bind to IL-17A and inhibit interaction with the IL-17 receptor, said Novartis, adding that the approval is based on the efficacy and safety outcomes from 10 Phase II and Phase III studies, including over 3,990 adult patients with moderate-to-severe plaque psoriasis, which demonstrated that Cosentyx resulted in clear or almost clear skin in the majority of patients and had an acceptable safety profile.

"The FDA's approval of Cosentyx signifies a turning point for psoriasis patients, who can now benefit from the first and only approved treatment targeting the IL-17 pathway, which is proven to play a key role in the development of plaque psoriasis," said David Epstein, division head of Novartis Pharmaceuticals. "This important milestone will now allow patients to receive a treatment that has the proven ability to offer clear or almost clear skin," he noted