FDA Advisory Committee negative for Brinavess for the rapid conversion of recent onset atrial fibrillation.- Correvio Pharma Corp.

Correvio Pharma Corp. announced that the FDA Cardiovascular and Renal Drugs Advisory Committee (CRDAC) met to review the Company's New Drug Application (NDA) seeking approval for Brinavess. The Committee jointly voted that the benefit-risk profile was not adequate to support approval (Vote: 2 Yes to 11 No).

Brinavess is Correvio's anti-arrhythmic drug that is currently under review by the FDA for the rapid conversion of recent onset atrial fibrillation (AF) in adult patients. While the FDA is not required to follow the committee's vote, the agency considers the committee's recommendations when making its decision. Correvio's NDA seeking approval for Brinavess is under review by the FDA with a target action date of December 24, 2019 under the Prescription Drug User-Fee Act (PDUFA).