Novartis Gains Label Expansion for Secukinumab

Novartis announced on Thursday that the FDA has approved a label update for secukinumab (Cosentyx) to include moderate to severe scalp psoriasis, a particularly challenging form of psoriasis to treat, and a condition that Novartis says affects approximately half of patients with psoriasis.

The label update was based on data from the phase 3 SCALP study of secukinumab versus placebo in 102 patients with scalp psoriasis. Patients were randomized to receive either 300 mg of secukinumab or placebo at weeks 0, 1, 2, and 3, and then every 4 weeks for 12 weeks. The proportion of patients who had an Investigator’s Global Assessment scalp-only score of 0 or 1 (clear or almost clear) during the study period were 56.9% for the secukinumab arm and 5.9% for the placebo arm.

Secukinumab was the first interleukin-17A inhibitor FDA-approved to treat moderate to severe plaque psoriasis, and the label update, says Eric Hughes, global development unit head of immunology and dermatology at Novartis, “…confirms the additional value Cosentyx offers to patients who seek a treatment effective in various areas of the body…we’re proud to expand treatment possibilities of Cosentyx for an even greater number of patients."

Already this year, Novartis released data from the head-to-head CLARITY study showing that secukinumab outperformed ustekinumab (Stelara) in treating psoriasis, and announced that it is initiating the SURPASS trial, a head-to-head clinical trial of secukinumab versus adalimumab in patients with ankylosing spondylitis. Already recruiting is the EXCEED trial, yet another head-to-head trial of secukinumab versus adalimumab in patients with psoriatic arthritis.

As the originator adalimumab (Humira) moves closer to patent expiry, secukinumab’s growing body of positive data may help it to compete for a substantial share of the inflammatory disease market against an increasing number of US- and EU-approved biosimilars. Already, secukinumab has become a top earner for Novartis, with 2017 sales of $615 million across all indications—up 53% from 2016—according to Novartis’ 2017 financial report.