FDA Approves New Treatment for Moderate-to-Severe Plaque Psoriasis

The FDA has approved Siliq (brodalumab) for the treatment of moderate-to-severe plaque psoriasis. The drug is administered by injection.

Brodalumab, the active ingredient in Siliq, works by binding to the protein that causes inflammation, thus inhibiting the inflammatory response that plays a role in the development of plaque psoriasis. Siliq has been approved for patients who are candidates for systematic therapy or phototherapy and have failed to respond to or stopped responding to other systemtic therapies.

Safety and efficacy of the drug was tested through 3 placebo-controlled clinical trials including 4373 adults. Participants on Siliq had clear or almost clear skin compared to the placebo, which was assessed by scoring the extent, nature, and severity of psoriatic changes.

Participants with a history of depression or suicidal thoughts had increased incidences of suicidal thoughts and behavior, but a causal association between suicide and Siliq has not been established.

Common adverse side effects reported were joint pain, headache, fatigue, diarrhea, throat pain, nausea, muscle pain, injection site reactions, influenza, low white blood cell count, and fungal infections.

—Melissa Weiss

Reference:

FDA. FDA approves new psoriasis drug [press release]. February 15, 2017. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm541981.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery