Ridaforolimus EMA Submission Pulled by Merck

Merck have suffered a hindrance this week with the withdrawal of their Marketing Authorization Application for ridaforolimus in Europe.

The European Medicines Agency (EMA) was evaluating ridaforolimus as a possible maintenance treatment for patients with soft tissue sarcoma or primary malignant bone tumour.  Merck have licensed the drug, an M-TOR inhibitor from Ariad Pharmaceuticals.

However, in a letter to the European regulator, Merck noted that they have decided to withdraw the application, as the Committee for Medicinal Products for Human Use (CHMP) has suggested that the available data is not adequate to authorise a licence for the drug.

Merck added that they are studying ridaforolimus together with additional therapies in various tumour types, and that the submission withdrawal earlier this week does not change their commitment to on-going clinical trials with the drug.

However, the withdrawal will still come as a blow to the company; especially as US regulators knocked back ridaforolimus for approval earlier this year.

In June, the US Food and Drug Administration (FDA) issued a complete response letter for ridaforolimus, requesting additional clinical trial(s) to further measure the safety and efficacy of the drug, which is also known as Taltorvic.


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