IDM's osteosarcoma drug gets CHMP OK

USA-based IDM Pharma says that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has recommended  the approval of Mepact (mifamurtide) for non-metastatic, resectable  osteosarcoma, a rare and often fatal bone tumor that typically affects  children and young adults.

The marketing authorization is likely to be issued by the European  Commission in first-quarter 2009.

IDM noted that Mepact would be the first approved new treatment in more  than 20 years for patients with the condition. The drug was granted  orphan medicinal product status in Europe in 2004 and is therefore  entitled to a period of 10 years market exclusivity in respect of the  approved indication.