Cosentyx Gains FDA Approval for Scalp Psoriasis Label Update

The FDA has approved a label update for secukinumab (Cosentyx) for the treatment of moderate-to-severe scalp psoriasis, according to a Novartis press release. Scalp psoriasis affects approximately half of patients with psoriasis and is notoriously difficult to treat due to the presence of hair and other related factors.

The label will be updated in the United States immediately, according to the release.

“Scalp psoriasis is on a very sensitive, and a very visible area of the body. For patients this could translate into physical pain, frustration and social isolation,” said Kristian Reich, MD, PhD, Georg-August-University Göttingen and Dermatologikum Hamburg, Germany. “Patients and doctors are in need of effective treatment options in this and other difficult-to-treat forms of psoriasis."

The label update is based on findings from the phase 3 SCALP study, which explored the safety and efficacy of secukinumab versus placebo among 102 patients with scalp psoriasis.

The primary endpoint was proportion of patients who achieved Psoriasis Scalp Severity Index 90 response rate at 12 weeks.

The researchers found that secukinumab demonstrated superior efficacy to placebo. Approximately 57% of patients treated with secukinumab achieved clear or almost clear scalp compared with only 5.9% of placebo-treated patients, according to the study.

Notably, secukinumab sustained long-term efficacy and had a favorable safety profile compared with placebo, according to the release.

Novartis said that secukinumab is the only fully human IL-17A inhibitor to show efficacy and safety in a dedicated trial of 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 and Dermatology, Novartis. "We're proud to expand treatment possibilities of Cosentyx for an even greater number of patients."