Valeant’s Brodalumab Delayed By FDA As REMS Is Negotiated
FDA notified the company the US review goal date for the psoriasis pill has been extended three months from Nov. 16 to Feb. 16.
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Psoriasis treatment brodalumab is first novel biologic approved since US FDA released its final guidance on nonproprietary naming for new biologics and biosimilars; agency says it didn't want to delay the approval by taking more time to develop a suffix.
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.
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