CV Therapeutics withdraws European application for ranolazine, to resubmit

By Angela McDaniels

Seattle, Oct. 25 - CV Therapeutics Inc. said it has withdrawn its application to the European Medicines Agency for authorization to market ranolazine for the treatment of chronic angina - but plans to resubmit it later with more information.

The agency indicated it cannot approve European use of CV's ranolazine without additional clinical pharmacokinetic information, the company said.

At this point in the process, the European centralized regulatory procedure does not provide a mechanism for obtaining and adding new information to a marketing authorization application, CV added. Accordingly, it has withdrawn its application and anticipates resubmitting it at a later date.

Based on dialog with the agency, CV said it expects one or more additional clinical pharmacokinetic studies will be required prior to any approval, but not a large or lengthy clinical trial.

In the United States, an amended new drug application for ranolazine for the treatment of chronic angina in a restricted patient population is currently under review by the U.S. Food and Drug Administration.

CV Therapeutics, headquartered in Palo Alto, Calif., is a biopharmaceutical company that applies molecular cardiology to the development of small-molecule drugs for the treatment of cardiovascular diseases.

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