Correvio Pharma Corp. (NASDAQ:CORV) (TSX:CORV), a specialty pharmaceutical company focused on commercializing hospital drugs, today announced it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for Brinavess™ (vernakalant IV), an anti-arrhythmic drug for the conversion of atrial fibrillation (AF). The CRL stated that the FDA determined it cannot approve the Brinavess NDA in its present form and provided recommendations needed for resubmission.
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.
Correvio 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 FDA's concerns and currently believes that enrollment of both US and ex-US subjects may be acceptable to the Agency based on preliminary feedback. As previously announced, Correvio is also exploring strategic alternatives for the Company and/or its assets. Potential strategic alternatives that may be evaluated include, but are not limited to, an acquisition, merger, business combination or other strategic transaction involving the Company or its assets.