“Mifamurtide, when added to combination chemotherapy in this large phase III trial, provided a significant benefit on disease free survival and on overall survival of young osteosarcoma patients. If approved, this product will represent an important therapeutic advancement for patients with this disease,” said Dr Ian Lewis, pediatric and adolescent oncologist at St. James University Hospital, Leeds in the UK.
The European Medicines Agency will evaluate the application to determine whether to recommend to the European Commission the approval of Mepact in the EU. Mepact was granted orphan drug status by the agency in 2004.
IDM Pharma’s European affiliate, IDM SA, was granted the status of “Pharmaceutical Establishment” by the French Health Agency in October. This status allows IDM SA to submit a marketing application to the European health authorities and to import and sell approved pharmaceutical products in the European Union.
The marketing application follows the submission of a new drug application for IDM Pharma’s Junovan for osteosarcoma to the FDA.