FDA keeps Cardiome, Astellas in limbo over AF drug

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The FDA has delayed its new drug application decision for the heart treatment drug, Kynapid (vernakalant hydrochloride) from Cardiome Pharma and its co-developer Astellas Pharma US.

The companies said that vernakalant is the intravenous formulation of an investigational drug being evaluated for the acute conversion of atrial fibrillation. The FDA did not provide an action letter prior to the PDUFA date of Jan. 19, according to the companies.

While the companies look forward to the FDA reaching a decision, they respect its need for additional time to review the Kynapid new drug application (NDA).

“Astellas and Cardiome strongly believe in the therapeutic value of Kynapid based on clinical trial data and are confident it will be an important therapy in the treatment of atrial fibrillation,” according to William E. Fitzsimmons, senior vice president of research and development at Astellas.

In October 2003, Cardiome granted the Deerfield, Ill.-based Astellas an exclusive license to develop and commercialize Kynapid in North America. The Vancouver, British Columbia-based Cardiome said it has retained all rights to the intravenous formulations outside of Canada, the United States and Mexico.