FDA approves Siliq for treatment of plaque psoriasis
Siliq was approved for patients with plaque psoriasis who have failed to respond to other systemic therapies.
(HealthDay News) — The injected drug Siliq (brodalumab) has been approved by the US Food and Drug Administration to treat moderate-to-severe plaque psoriasis in adults.
Siliq is approved for patients who've already failed to respond to other systemic therapies. The drug is designed to inhibit the body's inflammatory response that plays a role in the development of plaque psoriasis, the FDA said in a news release.
Saliq was evaluated in clinical studies involving 4,373 patients with moderate-to-severe plaque psoriasis. The most common side effects included joint pain, headache, fatigue, diarrhea, throat pain, nausea, muscle pain, and injection-site reactions.
More-serious potential side effects are suicidal thoughts and behavior, especially among patients with a history of suicidal behavior or depression, the FDA said. But "a causal association between treatment with Siliq and increased risk of suicidal ideation and behavior has not been established," the agency added. The drug's label will include a boxed warning of possible suicidal thoughts and behavior. The agency also warned against the drug's use by patients with Crohn's disease or active tuberculosis.
Siliq is marketed by Valeant Pharmaceuticals, based in Bridgewater, NJ
- US Food and Drug Administration. FDA approves new psoriasis drug [press release]. Published February 15, 2017. Accessed February 17, 2017.