Valeant’s Plaque Psoriasis Drug Gains FDA Approval

The US Food and Drug Administration (FDA) has approved Valeant’s injectable plaque psoriasis drug, Siliq (brodalumab). The drug is a monoclonal antibody designed to bind to the IL-17 receptor to inhibit the inflammatory response that contributes to the symptoms of plaque psoriasis.

Siliq has been approved to treat adult patients with moderate-to-severe plaque psoriasis. Patients who have been previously unresponsive to systemic therapy or phototherapy are candidates for treatment with Siliq.

“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 Dr. Julie Beitz, director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research. “Patients and their healthcare providers should discuss the benefits and risks of Siliq before considering treatment.”

Psoriasis is an autoimmune disorder characterized by flaky, red patches on the skin. Approximately 7.5 million Americans suffer from the skin condition, with 80 to 90 percent of these patients being diagnosed with plaque psoriasis.

“We believe Siliq fulfills a significant unmet medical need, and I am proud of our team’s success in developing and bringing to market this treatment for patients with moderate-to-severe plaque psoriasis,” said Joseph C. Papa, Chairman and CEO of Valeant. “We are pleased that Siliq will soon be available to help treat the suffering of adults who live with this debilitating, incurable condition, and further our mission to improve people’s lives with our healthcare products.”

Three placebo-controlled clinical trials with a combined enrollment of 4,373 patients with plaque psoriasis, were used to assess the safety and efficacy of Siliq. Compared to the placebo, patients treated with Siliq showed clear, or almost clear skin, as assessed by a scoring matrix of psoriasis severity.

“Siliq is the only product that has demonstrated 100% improvement in the psoriasis area and severity index (PASI 100) during clinical trials as a primary endpoint,” said Dr. Lawrence J. Green, associate clinical professor of Dermatology at George Washington University School of Medicine in Washington, D.C. “As the first IL-17 receptor A blocker that helps stop the proinflammatory cascade that leads to psoriasis, resulting in the normalization of skin inflammation, this is a significant achievement for the many patients who suffer with moderate-to-severe plaque psoriasis. Siliq will be a welcomed addition to my treatment armamentarium.”

Due to the observed risk of suicidal ideation or behavior in some patients taking Siliq, the drug carries an FDA black box warning. Because of this risk, the drug will only be available under a Risk Evaluation and Mitigation Strategy (REMS), which requires prescribers to be certified to counsel patients about the mental health risks.