FDA Approves Cosentyx Label Update to Include Scalp Psoriasis

Thursday, February 08, 2018 | FDA Approval/Clearance , Psoriasis , Product Launches and Updates , Novartis


The FDA has approved a label update for Novartis' Cosentyx (secukinumab), the first interleukin-17A (IL-17A) antagonist approved to treat moderate to severe plaque psoriasis. The updated label includes Cosentyx data in moderate to severe scalp psoriasis—one of the difficult-to-treat forms of the disease, which affects approximately half of all psoriasis patients. The label update is effective in the US immediately, and is based on the proven efficacy and consistent safety profile of Cosentyx from a dedicated Phase III scalp psoriasis trial.
 
The updated label for Cosentyx in scalp psoriasis addresses an important unmet need, according to the company. Scalp psoriasis can be challenging to treat with topical agents or phototherapy due to the presence of hair and other factors. Approximately half of all 125 million patients with psoriasis may suffer from scalp psoriasis.
 
“This is an important label update for Cosentyx, the first IL-17A inhibitor approved for moderate to severe plaque psoriasis. It confirms the additional value Cosentyx offers to patients who seek a treatment effective in various areas of the body,” said Eric Hughes, Global Development Unit Head, Immunology & Dermatology. “We’re proud to expand treatment possibilities of Cosentyx for an even greater number of patients.”
 
Cosentyx is currently the only fully human IL-17A antagonist to demonstrate efficacy and safety in a dedicated Phase IIIb study of scalp psoriasis. The label update is based on 12-week primary endpoint results from the US study of moderate to severe scalp psoriasis patients where Cosentyx (300 mg) demonstrated superior efficacy compared to placebo.
Cosentyx, in a separate study, has demonstrated sustained long-term efficacy, as well as a safety profile consistent with that seen in pivotal trials.7 To date, more than 125,000 patients worldwide have been prescribed Cosentyx in the post-marketing setting across all indications since launch.

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