FDA Supports Approval of Valeant’s Siliq for Psoriasis

An FDA advisory committee unanimously backed FDA approval of Valeant’s Siliq to treat plaque psoriasis, but was split on the risk management of the candidate due to reported suicides.

The committee found that the sponsor’s three Phase 3 clinical trials conclusively demonstrated the candidate’s efficacy in reducing the severity of psoriasis for patients who qualify for systemic therapy or phototherapy.

But six reported suicides during clinical trials prompted four of the panelists to vote for a warning label, a proposal that was rejected by the remaining 14 committee members as an inadequate management tool, given the uncertainty surrounding the candidate’s link to suicide.