Siliq Approved for Psoriasis
February 15, 2017 – The U.S. FDA approved Siliq™ (brodalumab), indicated to treat adults who have moderate-to-severe plaque psoriasis. Manufactured by Valeant, Siliq is a monoclonal antibody that selectively binds to the interleukin (IL)-17 receptor. By blocking the IL-17 receptor, Siliq interrupts the process of inflammation to reduce psoriasis activity. Siliq should be used in patients who are eligible for systemic (oral or injected) treatment or phototherapy, but already have tried systemic treatments that either stopped working or did not work at all. Recommended dosing is one subcutaneous (SC) injection (210mg) once a week for three doses, and then once every two weeks. In clinical trials, psoriasis was completely cleared for over 60% of the patients treated with Siliq for 12 weeks. More than eight of 10 actively treated patients showed 75% or more improvement.
Siliq has a boxed warning that it may cause patients to consider or try suicide. Its use will be regulated under a Risk Evaluation and Mitigation Strategy – Siliq REMS. Patients, physicians and pharmacies all must be authorized before using, prescribing or dispensing Siliq. Valeant plans on launching Siliq in the second half of 2017. It will be available through open distribution. Siliq will compete with Cosentyx® (secukinumab) manufactured by Novartis) and Taltz® (ixekizumab) manufactured by Lilly, which bind to the IL-17A cytokine, as opposed to Siliq, which binds to IL-17 receptors.
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- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
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