IDM submits Junovan NDA to FDA

California, USA-based biopharmaceutical company IDM Pharma says it has submitted a New Drug Application to the Food and Drug Administration requesting approval for its drug Junovan (mifamurtide for injection) as a treatment for osteosarcoma. Specifically, the NDA covers the agent's use in newly-diagnosed, resectable high-grade osteosarcoma sufferers who have experienced surgical resection in combination with multiple agent chemotherapy.

The condition is a childhood cancer that is associated with adolescent growth spurts, and is believed to affect around 1,000 patients in the USA each year.

The company added that the NDA includes efficacy and safety data from a Phase III trial of the drug in 678 children with the condition, which was conducted by the Pediatric and Children's oncology groups of the US National Cancer Institute. The results showed that participants who received the drug in combination with chemotherapy achieved a significant improvement in both disease-free and overall survival. The firm added that, at six years, the probability of survival of those treated with the drug in combination with chemotherapy was 77%, versus 66% in those who only received chemotherapy.