FDA holds decision on Kynapid leaving Cardiome waiting

Source: Healthcare Digital

Date :21/01/2008 07:06:16

Cardiome Pharma Corp said on Monday that it did not receive a decision from the U.S. Food and Drug Administration on its New Drug Application for its Kynapid heart treatment.

A decision on vernakalant hydrochloride, used in the treatment of atrial fibrillation, or abnormal heart rhythm, was expected by January 19.

Cardiome is in a co-development agreement on the treatment with the U.S. arm of Astellas Pharma Inc.

Astellas holds a North American license to develop and market the treatment, while Cardiome retain all rights to the intravenous formulations outside of Canada, the U.S. and Mexico.

Review

“While we look forward to the FDA reaching a decision, we respect their need for additional time to review the KYNAPID NDA,” said William E. Fitzsimmons, PharmD, Senior Vice President, Research & Development at Astellas.

He added that both Astellas and Cardiome are “confident” it will be an important therapy in the treatment of atrial fibrillation.

January 21, 2008