(Reuters) – The U.S. Food and Drug Administration has declined to approve Correvio Pharma Corp’s drug to correct irregular rhythm in the upper chambers of the heart, the company said on Tuesday.
In the so-called complete response letter, the FDA stated that while the submitted data provides substantial evidence of the drug’s effectiveness, the data does not provide reassuring evidence of Brinavess’ safety, the company said.
A panel of independent experts to the FDA earlier this month voted 11-2 against approving Brinavess, citing serious safety risks, including low blood pressure and irregular rhythm in the lower heart chambers during the trials.
Brinavess, currently available in 41 countries including the European Union and Canada, aims to restore normal heart rhythm in patients facing erratic rhythm due to a condition called atrial fibrillation or AFib.
The company said it intends to request a meeting with the FDA as soon as possible to discuss the design and specifics of a potential study to address the agency’s concerns.
A day after the FDA panel’s recommendation, Correvio said it was exploring options including a sale. The company’s U.S.-listed shares fell as much as 67% on the day. They were down 7% at 37 cents before the opening bell on Tuesday.
AFib is a common cardiac rhythm disturbance that can lead to serious problems such as stroke and heart failure if left untreated.
Current treatments include medicines to regulate heart rhythm, blood thinners to help prevent clot formation, and, in some cases, electric shocks to reset the heartbeat.
Correvio has been trying to get U.S. nod since 2006, but the FDA declined approval over safety concerns and later put the U.S. studies on hold after the death of a patient. The hold still remains in place.
DECEMBER 24, 2019