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Brinavess Rejected By Advisory Cmte., Leaving US FDA To Mull Lifting Clinical Hold On Correvio's AFib Drug

 
• By Michael Cipriano

Cardiovascular and Renal Drugs Advisory Committee voted 11-2 against approval for Correvio's atrial fibrillation drug Brinavess over cardiovascular safety concerns; the agency would have to lift the long-standing  clinical hold on the drug before the company can do any further study in humans.

FDA Advisory Committee Feature image

The US Food and Drug Administration's next step in its evaluation of Correvio Pharma Corp.'s atrial fibrillation (AFib) candidate Brinavess (vernakalant) will likely be to decide whether to lift the existing clinical hold on the drug following an 11-2 vote against approval from the Cardiovascular and Renal Drugs Advisory Committee.

An approval is almost certainly out of the cards, as the panel's 10 December vote lends strong support to the agency's existing view that the benefits of Brinavess do not outweigh its signals of serious

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