Siliq Approval History
- FDA approved: Yes (First approved February 15th, 2017)
- Brand name: Siliq
- Generic name: brodalumab
- Dosage form: Injection
- Company: Valeant Pharmaceuticals International, Inc.
- Treatment for: Plaque Psoriasis
Siliq (brodalumab) is a human anti-interleukin-17-receptor monoclonal antibody for the treatment of plaque psoriasis.
Siliq is for use in adult patients who are candidates for systemic therapy or phototherapy, and who have failed or stopped responding to other systemic therapies. The FDA approval of Siliq was based on the results of three randomized, placebo-controlled clinical studies of 4,373 patients. At week 12, a greater proportion patients receiving Siliq reported clear or almost clear skin compared to those treated with a placebo, and more than 50 percent of patients who received Siliq achieved total skin clearance within a year.
Siliq is administered via subcutaneous injection weekly for the first three doses, and then every two weeks. Siliq comes with a boxed warning to alert health care professionals and patients of the risk of suicidal ideation and behavior, and is only available only through a restricted program called the Siliq REMS Program. Common side effects include arthralgia, headache, fatigue, diarrhea, oropharyngeal pain, nausea, myalgia, injection site reactions, influenza, neutropenia, and tinea infections.
Development History and FDA Approval Process for Siliq
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