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Merck & Co Inc Provides Update On EU Marketing Authorization Application For Ridaforolimus


Thursday, 29 Nov 2012 08:00am EST 

Merck & Co Inc announced that it has formally notified the European Medicines Agency (EMA) of Merck's decision to withdraw the Marketing Authorisation Application (MAA) for ridaforolimus. The application for Marketing Authorisation for ridaforolimus was accepted by the EMA in August 2011. At the time of the withdrawal it was under review by the Agency`s Committee for Medicinal Products for Human Use (CHMP). In its letter to the EMA, Merck said that the withdrawal of ridaforolimus was based on the provisional view of the CHMP that the data available to date and provided in the Marketing Authorisation Application were not sufficient to permit licensure of ridaforolimus in the European Union for the maintenance treatment of patients with soft tissue sarcoma or primary malignant bone tumor. Although the application for these uses was withdrawn, Merck is studying ridaforolimus in combination with other drugs in other tumor types. The withdrawal of the European application of ridaforolimus for the maintenance treatment of patients with soft tissue sarcoma or primary malignant bone tumor does not change Merck`s commitment to the ongoing clinical trials with ridaforolimus. 

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