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 advising 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
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.