Merck & Co pulls EU marketing application for ridaforolimus
US drug giant Merck & Co (NYSE: MRK) says it has formally notified the European Medicines Agency of its decision to withdraw the Marketing Authorization Application (MAA) for ridaforolimus, which was filed last year for the treatment of patients with metastatic sarcomas (The Pharma Letter August 2, 2011).
At the time of the withdrawal ridaforolimus, which is being developed under license from Ariad Pharmaceuticals (Nasdaq: ARIA), 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 so far and provided in the MAA 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.
Company remains committed to ongoing clinical trials of the drug
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