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Siliq Approval History

Reviewed on Feb 15, 2017 by J.Stewart BPharm

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

Feb 15, 2017Approval FDA Approves Siliq (brodalumab) for Plaque Psoriasis
Jul 19, 2016FDA Advisory Committee Recommends Approval Of Brodalumab For Treatment Of Moderate-To-Severe Plaque Psoriasis
Jan 26, 2016Valeant Announces FDA Acceptance of BLA Submission for Brodalumab in Moderate-to-Severe Plaque Psoriasis
Sep  1, 2015AstraZeneca and Valeant Pharmaceuticals to Partner on Brodalumab
May 22, 2015Amgen to Terminate Participation in Co-Development and Commercialization of Brodalumab
Nov 25, 2014Amgen And AstraZeneca Announce Positive Results From Third And Final Pivotal Phase 3 Study Of Brodalumab
Nov 11, 2014Amgen And AstraZeneca Announce Positive Results From Second Pivotal Phase 3 Study Of Brodalumab

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