FDA approves Valeant's Siliq for plaque psoriasis

The FDA announced the approval of Valeant Pharmaceuticals' Siliq (brodalumab) to treat adults with moderate-to-severe plaque psoriasis. The agency noted that the injectable IL-17 receptor monoclonal antibody is intended for patients who are candidates for systemic therapy or phototherapy and have failed to respond, or have stopped responding to other systemic therapies.

In July last year, an FDA advisory committee voted unanimously in favour of recommending approval of Siliq on condition that the company implement certain measures aimed at mitigating potential suicide risk. For related analysis, read ViewPoints: Brodalumab at the FDA – everyone's a winner.

According to the FDA, because of the observed risk of suicidal ideation and behaviour seen in clinical studies, the product's labelling includes a boxed warning and the drug is only available through a restricted programme under a risk evaluation and mitigation strategy. The regulator noted that approval of Siliq was based on data from three studies, with results showing that more patients treated with Valeant's drug compared to placebo had skin that was clear or almost clear, as assessed by scoring of the extent, nature and severity of psoriatic changes of the skin.

AstraZeneca and Amgen initially co-developed Siliq under the terms of a 2012 agreement, which Amgen exited in 2015, citing "events of suicidal ideation and behaviour" that would likely result in restrictive labelling. AstraZeneca subsequently awarded Valeant an exclusive license to the drug in a deal that was amended last year to terminate the Canadian drugmaker's right to Siliq in Europe.