Correvio Pharma announced that the FDA would not be approving its anti-arrhythmic drug in its current form.
Correvio Pharma (NASDAQ:CORV,TSX:CORV) announced it received a letter from the US Food and Drug Administration (FDA) regarding its drug application for an anti-arrhythmic drug stating that the FDA would not be approving the drug in its current form.
As quoted in the press release:
In the CRL, 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.