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IDM Pharma Receives Not-Approvable Letter for Mifamurtide

August 27, 2007

IDM Pharma announced that it received a not-approvable letter from the FDA after completing the review of the new drug application (NDA) for the investigational drug mifamurtide (L-MTP-PE), formerly known as Junovan, for the treatment of nonmetastatic osteosarcoma, a rare and often fatal bone tumor that typically affects children and young adults.

The FDA has requested data from additional clinical trials to demonstrate the benefit of L-MTP-PE, as well as information or clarification with respect to other sections of the NDA, the company said.

In July, the company announced its intention to amend the NDA with additional survival data to bring L-MTP-PE to market as quickly as possible.

The company said it will continue working with the cooperative groups and investigative sites involved in the study to collect vital status on patients who participated in the Phase III clinical trial and for whom complete data were not available at the time of filing of the NDA in October 2006. It expects to submit an amendment to the NDA to the FDA by the first quarter of 2008.