IDM Pharma Submits New Drug Application to the FDA for Junovan™ (mifamurtide) in the Treatment of Osteosarcoma
IDM Pharma announced that the company has submitted an electronic New Drug Application (NDA) to the U.S. Food and Drug Administration (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 conducted by the Pediatric Oncology Group (POG) and the Children's Oncology Group (COG), sponsored by the Division of Cancer Treatment and Diagnosis of the National Cancer Institute (NCI). A summary of the data from the Phase III trial is provided below. 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.
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