WHITEHOUSE STATION, N.J. and CAMBRIDGE, Mass. -- Merck and ARIAD Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for filing and review the New Drug Application (NDA) for ridaforolimus, an investigational oral mTOR inhibitor under development for the treatment of metastatic soft-tissue or bone sarcomas in patients who had a favorable response to chemotherapy, according to a press release.
FDA plans to conduct a standard 10-month review of their application.
European Medicines Agency had accepted the marketing authorization application for ridaforolimus.
As part of an exclusive license agreement with ARIAD, Merck is responsible for the development and worldwide commercialization of ridaforolimus in oncology.ARIAD intends to co-promote ridaforolimus in the United States.