IDM PHARMA SUBMITS NDA FOR BONE CANCER TREATMENT

IDM Pharma has submitted an electronic new drug application (NDA) to the FDA for Junovan (mifamurtide for injection), requesting approval for its use in the treatment of newly diagnosed resectable high grade osteosarcoma patients following surgical resection in combination with multiple-agent chemotherapy.

The Junovan NDA submission includes efficacy and safety data from 678 patients with non-metastatic resectable osteosarcoma, 332 of whom received Junovan, and from 115 patients with metastatic or unresectable osteosarcoma, 39 of whom received Junovan, in the controlled Phase III trial sponsored by the National Cancer Institute. The biological effects and safety of Junovan are further supported by data from 17 Phase I and II clinical studies performed by Ciba-Geigy in which an additional 248 patients received at least one dose of Junovan.

IDM requested that the FDA consider granting this NDA priority-review status, which could shorten review time from the standard 10 months to six months if granted. The FDA and the European Medicines Evaluation Agency (EMEA) have granted orphan drug status to Junovan.

Junovan is a fully synthetic lipophilic derivative of the muramyl dipeptide. When encapsulated in liposomes, MTP-PE is delivered selectively to macrophages via the scavenger lipoprotein receptor pathway. When the multilamellar liposomes are degraded inside the macrophage, MTP-PE is released, activating tumoricidal activity through the cytoplasmic Nod2 receptor.