FDA Approves Treatment for Moderate-to-Severe Plaque Psoriasis

The FDA has approved Valeant Pharmaceuticals’ Siliq (brodalumab) injection for subcutaneous use in adults with psoriasis. Siliq is indicated to treat moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy, and have failed to respond to other systemic therapies.

Siliq works by targeting the IL-17 receptor in patients, preventing the body from receiving signals that may lead to inflammation and preventing skin cells from accumulating. The approval is based on 3 clinical studies that showed 50% of patients who used Siliq achieved total skin clearance within a year.

“Moderate-to-severe plaque psoriasis can cause significant skin irritation and discomfort for patients, and today’s approval provides patients with another treatment option for their psoriasis,” Julie Beitz, MD, director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research, said in a press release. “Patients and their health care providers should discuss the benefits and risks of Siliq before considering treatment.”

Siliq was approved with a Risk Evaluation and Mitigation Strategy, and has a boxed warning label discussing observed risks in patients with a history of suicidal thoughts or behavior. Adverse effects associated with the drug include headache, arthralgia, fatigue, oropharyngeal pain, and diarrhea.

Reference

FDA approves new psoriasis drug [news release]. FDA’s website. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm541981.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery. Accessed Feb. 15, 2017.