The European Medicines Agency (EMEA) has indicated CV Therapeutics that additional clinical pharmacokinetic information would be needed prior to potential approval of ranolazine in Europe for the treatment of chronic angina. At this point in the process, the European centralised regulatory procedure does not provide a mechanism for obtaining and adding new information to a marketing authorisation application (MAA).
Accordingly, the company has withdrawn its MAA for ranolazine in Europe, and anticipates resubmitting it at a later date. Based on dialogue to date with the EMEA, the company expects one or more additional clinical pharmacokinetic studies will be required prior to any approval, but does not expect that a large or lengthy clinical trial would be required. The company plans to continue working with the EMEA to further clarify the next steps to support the potential resubmission and approval of ranolazine in Europe and has not determined a target date for resubmission of an MAA, states a company release.
In the United States, an amended new drug application (NDA) for ranolazine for the treatment of chronic angina in a restricted patient population is currently under review by the US Food and Drug Administration. This amended NDA includes the results of the ERICA study, which was conducted under the FDA's special protocol assessment (SPA) process. The NDA amendment was submitted as a complete response to an October 2003 approvable letter, and the Prescription Drug User Fee Act date for FDA action on the NDA is January 27, 2006. The SPA agreement is an agreement between CV Therapeutics and the FDA and does not apply to European regulatory authorities.
CV Therapeutics, Inc., headquartered in Palo Alto, California, is a biopharmaceutical company focused on applying molecular cardiology to the discovery, development and commercialisation of novel, small molecule drugs for the treatment of cardiovascular diseases.