Correvio Pharma said that the US Food and Drug Administration (FDA) decided not to approve its anti-arrhythmic drug Brinavess (vernakalant IV).
In this connection, the Canadian specialty pharma company has been issued a complete response letter (CRL) from the FDA stating that it cannot approve the new drug application (NDA) for Brinavess in its present form. The regulator is also said to have given recommendations needed for the resubmission of the drug, said Correvio Pharma.
The Canadian pharma company was seeking FDA approval for Brinavess for the conversion of atrial fibrillation (AF).
According to the FDA, the submitted data by Correvio Pharma offers substantial evidence of the effectiveness of the anti-arrhythmic drug, however, the data does not present reassuring evidence of its safety.
The FDA indicated that the Canadian pharma company will have to develop an approach to pick patients who have low risk of adverse cardiovascular reactions. Furthermore, the regulator said that that data from an additional, potentially uncontrolled, clinical study will be required to assess the drug’s cardiovascular risk in the selected patient population to back an NDA resubmission.
The US drug regulator also stated that the risk of serious cardiovascular adverse reactions will have to be much less than 1% in the selected patient population.
The Canadian pharma company stated: “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.”
The company said that it is also looking for strategic alternatives for its overall business and/or its assets, including an acquisition, merger, business combination, or other types of transaction.