Research & Development
Novartis awarded US FDA's approval for Cosentyx label update to include moderate to severe scalp psoriasis
9 February 2018 -

Novartis reported on Thursday the receipt of the US Food and Drug Administration's (FDA) label update for the first interleukin-17A (IL-17A) antagonist Cosentyx (secukinumab) for the treatment of moderate to severe plaque psoriasis with immediate effect.

The company said the US FDA approval follows a similar European label update in June 2017.

This US FDA's updated label includes Cosentyx data in moderate to severe scalp psoriasis. The 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 125m patients with psoriasis may suffer from scalp psoriasis.

According to the company, 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.

Under a separate study, Cosentyx has demonstrated sustained long-term efficacy, as well as a safety profile consistent with that seen in pivotal trials. To date, more than 125,000 patients worldwide have been prescribed Cosentyx in the post-marketing setting across all indications since launch, added the company

Plaque psoriasis is the most common form of psoriasis and appears as raised, red patches covered with a silvery white build-up of dead skin cells