Cardiome, Astellas file NDA for atrial fibrillation drug RSD1235

By Lisa Kerner

Erie, Pa., March 31 - Cardiome Pharma Corp. and its co-development partner, Astellas Pharma US, Inc., submitted a New Drug Application to the Food and Drug Administration seeking approval to market the intravenous formulation of RSD1235, an investigational drug for the acute conversion of atrial fibrillation, an abnormal heart rhythm.

The NDA is based on a five-year clinical development program for RSD1235, according to a company news release.

Once approved, the drug will be marketed in the United States by Astellas Pharma US, a U.S. subsidiary of Astellas Pharma, Inc.

In October 2003, Cardiome granted Astellas an exclusive license to develop and commercialize the intravenous formulation of RSD1235 in North America.

Cardiome said it retained all rights to the intravenous formulations outside of Canada, the United States and Mexico, as well as worldwide rights to oral RSD1235.

A trade name for the marketed product has not yet been determined.

"The submission of this NDA represents the culmination of years of clinical development effort, and is certainly the most exciting milestone we have yet achieved as a company," Cardiome chief executive officer Bob Rieder said in the release.

Cardiome is a cardiovascular drug-development company based in Vancouver, B.C.

Astellas Pharma is a research-based pharmaceutical company based in Deerfield, Ill.

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