WASHINGTON — The U.S. Food and Drug Administration approved Valeant Pharmaceuticals’s Siliq (brodalumab) to treat adults with moderate-to-severe plaque psoriasis.
Siliq is administered as an injection. It is intended for patients who are candidates for systemic therapy (treatment using substances that travel through the bloodstream, after being taken by mouth or injected) or phototherapy (ultraviolet light treatment) and have failed to respond, or have stopped responding to other systemic therapies.
"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," said Julie Beitz, M.D., director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research. "Patients and their health care providers should discuss the benefits and risks of Siliq before considering treatment."
Psoriasis is a skin condition that causes patches of skin redness and flaking. According to the FDA, Siliq’s safety and efficacy were established in three randomized, placebo-controlled clinical trials with a total of 4,373 adult participants with moderate-to-severe plaque psoriasis who were candidates for systemic therapy or phototherapy. More patients treated with Siliq compared to placebo had skin that was clear or almost clear, as assessed by scoring of the extent, nature and severity of psoriatic changes of the skin.