Posted by Michael Wonder on 25 Dec 2019
Correvio receives complete response letter from U.S. FDA for Brinavess and provides update on recent events
24 December 2019 - Correvio Pharma today announced it has received a complete response letter from the U.S. FDA regarding the new drug application for Brinavess (vernakalant IV), an anti-arrhythmic drug for the conversion of atrial fibrillation.
The letter stated that the FDA determined it cannot approve the Brinavess application in its present form and provided recommendations needed for resubmission.
In the letter, the FDA stated that while the submitted data provides substantial evidence of Brinavess' effectiveness, the data do not provide reassuring evidence of Brinavess' safety. The FDA indicated that Correvio will need to develop an approach to select patients who are at low risk of adverse cardiovascular reactions and that data from an additional, potentially uncontrolled, clinical study will be needed to assess Brinavess' cardiovascular risk in the selected patient population and to support an NDA resubmission. The FDA also stated that the risk of serious cardiovascular adverse reactions will need to be much less than 1% in the selected patient population.
