In the company’s news yesterday,
IDM Pharma Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) released a positive review of IDM’s L-MTP-PuE, or MEPACT, to treat resectable osteosarcoma. The committee also recommended that IDM receive authorization for centralized marketing of L-MTP-PuE in Europe through the European Commission. The company anticipates approval in early 2009.
Timothy P. Walbert, president and CEO of IDM, said the positive opinion will help IDM launch L-MTP-PuE into the market, benefiting the company as well as cancer patients and their families.
“The recommendation for approval by the CHMP is a great victory for many young patients and their families and is a significant step for the company in bringing this important treatment to market,” Walbert stated in the press release. “The committee’s decision validates the clinical trial data and the belief of investigators, patients and IDM Pharma that L-MTP-PE provides a significant overall survival benefit for osteosarcoma patients and meets a significant unmet treatment need.”
Centralized marketing authorization will allow for the exclusive marketing of L-MTP-PuE for 10 years in the 27 Member States of the European Union, as well as in Iceland, Liechtenstein and Norway. This will mark the first approved new treatment for osteosarcoma in more than 20 years.
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