FDA Approves New Psoriasis Treatment

The FDA today approved Novartis’ secukinumab (Cosentyx), an interleukin-17A antagonist, for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

The safety and effectiveness of Cosentyx were determined in 4 placebo-controlled studies that enrolled a total of 2,403 plaque psoriasis patients who were candidates for systemic therapy or phototherapy. The research team found that Cosentyx resulted in clearer skin, as measured by Psoriasis Area and Severity Index scores, compared with placebo at Week 12.

“The FDA's approval of Cosentyx signifies a turning point for psoriasis patients, who can now benefit from the first and only approved treatment targeting the IL-17 pathway, which is proven to play a key role in the development of plaque psoriasis,” said Novartis Pharmaceuticals Division Head David Epstein in a press release. “This important milestone will now allow patients to receive a treatment that has the proven ability to offer clear or almost clear skin.”

“Plaque psoriasis can cause significant skin irritation and discomfort for patients, so it is important to have a variety of treatment options available to patients,” added Amy Egan, MD, MPH, deputy director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research.

The most common adverse events experienced by trial patients treated with Cosentyx included diarrhea and upper respiratory infections. The use of Cosentyx has also been associated with serious allergic reactions. Cosentyx is being approved with a Medication Guide which informs patients that Cosentyx increases the risk of getting an infection due to the way in which the drug affects the immune system.