BioWorld International Correspondent
PARIS - IDM Pharma Inc. submitted a marketing authorization application to the European Medicines Agency (EMEA) for Mepact, its injectable formulation of mifamurtide, for osteosarcoma.
The application was filed in electronic common technical document format and specified that Mepact is to be used on patients with newly diagnosed, resectable, high-grade osteosarcoma following surgical resection in combination with postoperative, multi-agent chemotherapy.
Mepact is the name used in Europe for the product known as Junovan in the U.S. In late October, IDM Pharma, of San Diego, filed a new drug application with the FDA for Junovan for osteosarcoma. Junovan/Mepact was granted orphan drug status by both the FDA and the European Medicines Agency in 2004, and IDM is hoping the drug will be given fast-track approval.
IDM's European subsidiary, IDM SA, of Paris, was granted the status of "pharmaceutical establishment" by the French Health Products Safety Agency (AFSSAPS) in October, to add to its existing status of "cell therapy establishment."
That additional status permits IDM SA to submit an MAA to the EMEA, as well as to import and sell approved pharmaceutical products in all member states of the European Union.