Correvio Pharma Corp. said the U.S. Food and Drug Administration's cardiovascular and renal drugs advisory committee voted 11-2 against approval of its irregular heartbeat drug Brinavess.
The panel determined that the benefit-risk profile of Brinavess, or vernakalant, was not adequate to support approval. The FDA, which is expected to announce a decision on the drug's application by Dec. 24., considers the committee's recommendation but is not obliged to follow it.
Brinavess is approved in 41 countries outside the U.S., Correvio noted in its Dec. 10 press release.
Vancouver, British Columbia-based Correvio resubmitted a new drug application to the U.S. FDA in June after the regulator rejected a 2017 resubmission request for Brinavess. The agency deemed the earlier application insufficient.
The U.S. regulator accepted the Canadian drugmaker's resubmitted application for Brinavess in July to treat a type of atrial fibrillation, or an irregular heartbeat, in adults.
Atrial fibrillation increases the risk of stroke and heart failure. The American Heart Association expects that 12 million U.S. citizens will be affected by atrial fibrillation by 2030.
Correvio based the resubmitted application on results from a post-approval safety study called Spectrum, which was conducted with 1,778 patients in Europe. The trial showed that 70.2% of all patients treated with Brinavess saw their heart rhythm converted into a normal sinus rhythm.
Trading of Correvio's shares was halted on the Nasdaq and the Toronto Stock Exchange prior to the FDA's advisory committee meeting.