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news.The Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) has accepted Merck and ARIAD Pharmaceuticals' new drug application (NDA) of ridaforolimus for review.
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Ridaforolimus is an experimental oral mTOR inhibitor developed as a treatment for patients with metastatic soft-tissue or bone sarcomas who had a favorable response to chemotherapy.
Earlier, ARIAD and Merck entered into a licensing deal, under which Merck is responsible to develop and commercialize ridaforolimus in oncology.
ARIAD plans to co-promote ridaforolimus in the US.
Merck Global Human Health Oncology Franchise senior vice president and general manager Marty Duvall said this acceptance of the EMA filing for review is an important milestone as they seek to bring forward a potential treatment option for patients with metastatic bone and soft tissue sarcomas.