The FDA has approved a label update for the plaque psoriasis treatment.
Cosentyx has been granted a label update following the results of a dedicated Phase III scalp psoriasis trial. The data is surrounding moderate to severe scalp psoriasis, which affects approximately half of patients and is a notably difficult-to-treat form of the disease. This label update will be effective in the US immediately.
"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."
The disease affects approximately 125 million people worldwide. At present, Cosentyx is the only fully human IL-17A antagonist able to demonstrate efficacy and safety in a dedicated Phase IIIb study of scalp psoriasis. The drug was launched in 2015. This label update was based on 12-week primary endpoint results from the US study of moderate to severe scalp psoriasis patients where Cosentyx (300 mg) demonstrated results in comparison with a placebo.
Cosentyx works by specifically targeting IL-17A, which is an important cytokine involved in the development of psoriasis. IL-17A plays a significant role in the pathogenesis of plaque psoriasis, PsA and AS. Inhibiting IL-17A can be significant in treatment—up to 30% of patients with psoriasis may have PsA.
