(Reuters) – Independent experts to the U.S. Food and Drug Administration on Tuesday voted against Correvio Pharma Corp’s drug to correct irregular rhythm in the upper chambers of the heart in adult patients.
The panel voted 11-2 against approval of the drug, Brinavess, citing serious safety risks.
Brinavess, currently available in 41 countries including the European Union and Canada, aims to restore normal heart rhythm in patients experiencing erratic rhythm due to a condition known as atrial fibrillation, or AFib.
The FDA is slated to announce a final decision by Dec. 24. It is not mandated to follow the recommendation of the panel, but generally does.
Correvio first filed a marketing application for Brinavess in 2006, but safety concerns led the FDA to decline approval and U.S. trials were later put on hold following the death of a patient treated with the drug. The hold still remains in place.
Reporting by Saumya Sibi Joseph and Dania Nadeem in Bengaluru; Editing by Sriraj Kalluvila