LAVAL, QC – The U.S. Food and Drug Administration has approved Valeant Pharmaceuticals’ drug SILIQ™ (brodalumab) as a treatment for adults with moderate-to-severe plaque psoriasis.
Plaque psoriasis is the most common type of psoriasis, a chronic, noncommunicable, skin disease. The disease alters the life cycle of skin cells, causing them to build up rapidly on the surface of the skin.
The FDA approval includes a “Black Box Warning “for the risks in patients with a history of suicidal thoughts or behavior. The drug was approved with a Risk Evaluation and Mitigation Strategy (REMS) involving a one-time enrollment for physicians and one-time informed consent for patients.
The drug is a monoclonal antibody that targets the IL-17 receptor for patients with moderate-to-severe plaque psoriasis. SILIQ works by binding to IL-17RA with high affinity, therefore blocking the inflammatory downstream activity of IL-17A, IL-17F, IL-17A/F heterodimer and IL-17E. By targeting the IL-17 receptor, SILIQ prevents skin cells from accumulating. In three clinical studies that have been completed, more than 50 per cent of patients who used SILIQ achieved total skin clearance within a year.
It is indicated for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies.
“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.”
Valeant says it expects to commence sales and marketing of SILIQ in the U.S. in the second half of 2017.