IDM Pharma, a biopharmaceutical company, has announced that the European Commission has formally granted a centralized marketing authorization for Mepact for the treatment of patients with non-metastatic, resectable osteosarcoma.
The centralized marketing authorization allows Mepact to be marketed in the 27 member states of the EU, as well as in Iceland, Liechtenstein and Norway. Mepact was granted orphan medicinal product status in Europe in 2004 and under European pharmaceutical legislation is entitled to a period of 10 years market exclusivity in respect of the approved indication.
The approval was based on the Phase III Mepact trial (INT-0133), a National Cancer Institute funded cooperative group study conducted by the Children’s Oncology Group and the largest study ever completed in osteosarcoma, enrolling approximately 800 patients.
Timothy Walbert, CEO of IDM Pharma, said: Today’s approval of Mepact is a significant milestone for physicians and patients in Europe, giving them access to the first new osteosarcoma treatment option in 20 years. As our lead product candidate and first to receive approval, this is also a major milestone for IDM Pharma.
We look forward to amending the new drug application for mifamurtide in the US and continuing to work toward bringing this important treatment to market in the US.