Correvio Pharma Corp. said the U.S. Food and Drug Administration rejected its irregular heartbeat drug Brinavess, in line with the recommendations of one of its advisory committees.
The Vancouver, British Columbia-based company said that while the regulator found the medicine to be effective, it raised concerns related to its safety. Brinavess, or vernakalant, is approved in 41 countries outside the U.S. for atrial fibrillation, or an irregular heartbeat, in adults.
The U.S. FDA's cardiovascular and renal drugs advisory committee recently voted against the approval of Brinavess for similar reasons. While the FDA is not required to follow the committee's vote, the recommendation is taken into consideration.
The regulator has asked Correvio to conduct another clinical study assessing patient safety if the company plans to pursue approval of the medicine again. This is the second time the agency has rejected the drug.
After the FDA advisory committee rejection, Correvio said it was exploring strategic alternatives for the business and was planning to reduce its operating costs outside its core commercial business.