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news.IDM Pharma, a developer of cancer products, has announced that the Committee for Medicinal Products for Human Use has formally adopted a positive opinion for mifamurtide, known as Mepact in Europe, for the treatment of patients with non-metastatic, resectable osteosarcoma, a rare and often fatal bone tumor that typically affects children and young adults.
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The formal adoption of the positive opinion follows the Committee for Medicinal Products for Human Use recommendation previously announced in November 2008. The marketing authorization is likely to be issued by the European Commission in the first quarter of 2009.
Granting of the centralized marketing authorization will allow mifamurtide (L-MTP-PE) to be marketed in the 27 member states of the EU, as well as in Iceland, Liechtenstein and Norway. L-MTP-PE was granted orphan medicinal product status in Europe in 2004. Therefore, under European pharmaceutical legislation, L-MTP-PE is entitled to a period of 10 years market exclusivity in respect of the approved indication.
The company is expected to implement a pharmacovigilance plan for Mepact, as is normally required for all medicinal products, as part of the marketing authorization.