FDA has refused to approve Correvio Pharma Corp’s drug to correct irregular rhythm in the upper chambers of the heart, the corporate said on Tuesday.
In the so-called complete response letter, the FDA acknowledged that while the submitted data offers substantial evidence of the drug’s effectiveness, the information doesn’t provide reassuring evidence of Brinavess’ security, the corporate said.
A board of separate experts to the FDA earlier this month voted 11-2 against approving Brinavess, citing severe safety risks, along with low blood pressure and irregular rhythm in the lower heart chambers during the trials.
Brinavess, at present, available in 41 nations such as the European Union and Canada, aims to revive normal heart rhythm in sufferers facing erratic rhythm due to a condition called atrial fibrillation or AFib.
The corporate stated it intends to request a meeting with the FDA as soon as possible to talk about the design and specifics of a potential study to deal with the company’s concerns.
A day after the FDA committee’s recommendation, Correvio stated it was exploring options, including a sale. The firm’s U.S.-listed shares dropped up to 67% on the day. They were down 7% at 37 cents before the opening on Tuesday.
AFib is a common cardiac rhythm agitation that can result in severe issues such as stroke and heart failure if left untreated.
Current remedies include medicines to regulate heart rhythm, blood thinners to help prevent clot development, and, in some cases, electric shocks to recover the heartbeat.