FDA Approves New Indication For Plaque Psoriasis Treatment
The FDA approved a label update for secukinumab (Cosentyx) to include moderate-to-severe scalp psoriasis. This update was effective immediately.
Secukinumab is a fully human IL-17A inhibitor that has been approved to treat plaque psoriasis, nail psoriasis, psoriatic arthritis, and ankylosing spondylitis.
Approval for this new indication was based on data from a dedicated phase 3 study that included 102 patients with moderate-to-severe scalp psoriasis. Overall, 56.9% of patients who received secukinumab achieved Investigator's Global Assessment scalp of 0 or 1 compared with 5.9% of patients who received placebo.
Adverse effects associated with secukinumab included Crohn disease, diarrhea, nasopharyngitis, and an increased risk for infections, including tuberculosis.