Suicide Warnings For Valeant’s Siliq Could Hinder Access To Psoriasis Treatment
While an FDA advisory committee unanimously supported approval of the plaque psoriasis drug brodalumab, several recommended a black box warning on suicide risk that could limit sales of the drug.
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The third IL-17 inhibitor on the US market will have a $3,500/month list price. But in a crowded, safety-conscious space like psoriasis, it's unclear how low the discounted price will need to go and whether competitive pricing would be enough to sway prescribers.
A Black Box warning on suicidal ideation and behavior, a REM program and a Medication Guide may hold back the sales growth of Valeant’s new psoriasis therapy in the US, Siliq, following its Feb. 15 approval, although the drug has been associated with high levels of total skin clearance, a finding that could differentiate it from competing products.
FDA notified the company the US review goal date for the psoriasis pill has been extended three months from Nov. 16 to Feb. 16.