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Brinavess' US Review: EU Postmarket Data Unlikely To Save Troubled AFib Drug

 
• By Michael Cipriano

Correvio's atrial fibrillation drug Brinavess will return to a US FDA advisory committee more than a decade after the agency first declined to approve the drug;  FDA still has a series of cardiovascular safety concerns related to the drug and is not convinced by data from the European experience.

FDA Advisory Committee Feature image

It doesn't appear that European postmarketing data will save Correvio Pharma Corp.'s embattled atrial fibrillation (AFib) drug Brinavess (vernakalant) in the US.

The US Food and Drug Administration's Cardiovascular and Renal Drugs Advisory Committee will evaluate Brinavess, for a second time, at a 10 December meeting, as the agency's concerns about the drug's safety profile have

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