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# FDA Panel Backs Valeant Psoriasis Therapy With Risk Plan
- URL: https://www.fdaweb.com/fda-panel-backs-valeant-psoriasis-therapy-with-risk-plan/
- Published: 2016-07-20T12:00:00.000Z
- Updated: 2026-09-14T21:16:09.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5136234

FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee has voted 18 to 0 to recommend approval of aValeant BLA for Siliq (brodalumab) injection for treating plaque psoriasis. Fourteen panel members recommended thatrisk management options for “suicide ideation and behavior” outside of the approved labeling be implemented if approved. Four panel members said labeling would be sufficient to manage risks.

While FDA reviewers said the submission’s data showed the therapy superior to placebo in reducing psoriasis severity after 12 weeks of treatment, they also raised some safety concerns with the submission ([see earlier story](https://www.fdaweb.com/fda-reviewers-have-safety-concerns-with-valeant-psoriasis-drug/)). “In the Phase 3 clinical trials of psoriasis, a total of 23 treatment-emergent fatal events were reported in brodalumab-treating subjects,” an agency [briefing document](http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/DermatologicandOphthalmicDrugsAdvisoryCommittee/UCM511357.pdf?ref=fdaweb.com) noted. “The largest category was comprised of 13 cardiovascular-related events, including MI (four), sudden death/cardiac arrest (three), cerebrovascular accident (two), and other single events (four). There were a total of four completed suicides, including one reported as an intentional overdose, three accidental deaths related to motor vehicle accidents and three other single unrelated fatal events.”