FDA staff concerned on suicide risk of Valeant's Siliq for psoriasis

Briefing documents prepared for a US Food and Drug Administration advisory committee have raised concerns on a potential suicide risk involving Siliq (brodalumab), a psoriasis treatment being developed by Canada’s Valeant Pharmaceuticals (VRX.TO).

Valeant has submitted a biologics licensing application to the regulator for Siliq to treat moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

It is to be considered by the FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee tomorrow (Tuesday), and this panel has been presented with a report written by agency staff which analyses Valeant’s application.