(Reuters)—The U.S. Food and Drug Administration has approved Valeant Pharmaceuticals International Inc.’s brodalumab (Siliq) to treat adults with moderate to severe plaque psoriasis. Brodalumab is administered as an injection.
Brodalumab is intended for patients who are candidates for systemic therapy or phototherapy and have failed to respond, or have stopped responding to other systemic therapies, the FDA says.
“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,” Dr. Julie Beitz, director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research, says in a statement. “Patients and their health care providers should discuss the benefits and risks of [brodalumab] before considering treatment.”
Psoriasis is an autoimmune disorder that occurs more commonly in patients with a family history of the disease, and most often begins in people between the ages of 15 and 35. Plaque psoriasis, in which patients develop thick, red skin with flaky, silver-white scales, is the most common form of the disease.
Brodalumab’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 brodalumab compared with 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, the FDA says.
The approval for brodalumab includes a labeling with boxed warning to mitigate the risk of suicide. Patients treated with brodalumab during clinical trials had shown suicidal behavior, the FDA notes.