Cardiome Pharma and its co-development partner Astellas Pharma US have received an action letter from the FDA for Kynapid injection for the treatment of atrial fibrillation, a potentially life-threatening condition that occurs when electrical signals in the heart malfunction.

Kynapid is under review for the rapid conversion of atrial fibrillation to sinus rhythm.
In the action letter, the FDA informed the sponsor (Astellas) that it has completed its review of the Kynapid new drug application and that the application is approvable. Prior to considering approval, the FDA requires additional information associated with the risk of previously identified events experienced by a subset of patients during the clinical trials in order to assure an acceptable risk benefit profile compared to electrical cardioversion.

The FDA has also requested a safety update from ongoing or completed studies of vernakalant, regardless of indication, dosage form or dose level. Cardiome and Astellas said that they will work closely with the FDA to address all issues raised in the approvable letter.

Bob Rieder, CEO and chairman of Cardiome, said: "Astellas will be in contact with the FDA within the next few days to discuss next steps, and we expect that several months may be required to assemble a complete and appropriate response. While this action letter could result in the need for an additional clinical study, Cardiome is optimistic that the questions raised can be satisfactorily addressed from currently available data."