FDA requires more info from Cardiome prior approving a-fib drug
Cardiome Pharma’s stock plunged Monday after the FDA requested additional information for Kynapid injection for the treatment of atrial fibrillation, which may require the company to conduct more clinical studies.
Kynapid (vernakalant hydrochloride) injection is under review for the rapid conversion of atrial fibrillation (AF) to sinus rhythm, according to Cardiome and its co-developer, Astellas Pharma US.
In the action letter, the FDA informed the sponsor, Astellas, that it has completed its review of the Kynapid new drug application (NDA) and that the application is approvable.
However, prior to considering approval, FDA said it 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.
FDA has also requested a safety update from ongoing or completed studies of vernakalant, regardless of indication, dosage form, or dose level.
The Vancouver, Canada-based Cardiome and Deerfield, Ill.-based Astellas said that they will work closely with the FDA to address all issues raised in the approvable letter.
“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,” stated Bob Rieder, CEO and chairman of Cardiome.
In October 2003, Cardiome granted Astellas an exclusive license to develop and commercialize Kynapid in North America. Cardiome retains global rights to vernakalant (oral) for the prevention of AF recurrence and all rights to the intravenous formulations outside of Canada, U.S. and Mexico. The NDA for Kynapid, based on a five-year clinical development program, was submitted in December 2006.
Kynapid (vernakalant hydrochloride) injection is under review for the rapid conversion of atrial fibrillation (AF) to sinus rhythm, according to Cardiome and its co-developer, Astellas Pharma US.
In the action letter, the FDA informed the sponsor, Astellas, that it has completed its review of the Kynapid new drug application (NDA) and that the application is approvable.
However, prior to considering approval, FDA said it 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.
FDA has also requested a safety update from ongoing or completed studies of vernakalant, regardless of indication, dosage form, or dose level.
The Vancouver, Canada-based Cardiome and Deerfield, Ill.-based Astellas said that they will work closely with the FDA to address all issues raised in the approvable letter.
“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,” stated Bob Rieder, CEO and chairman of Cardiome.
In October 2003, Cardiome granted Astellas an exclusive license to develop and commercialize Kynapid in North America. Cardiome retains global rights to vernakalant (oral) for the prevention of AF recurrence and all rights to the intravenous formulations outside of Canada, U.S. and Mexico. The NDA for Kynapid, based on a five-year clinical development program, was submitted in December 2006.