NDA will be resubmitted with additional information and clarifications in Q1 2008.
IDM Pharma received a not approvable letter from the FDA regarding the NDA filed for the drug mifamurtide (L-MTP-PE) for the treatment of nonmetastatic osteosarcoma. The company’s value fell almost 30% to open trading at $1.63.
FDA has requested data from additional clinical trials to demonstrate the benefit of the compound. FDA also has requested information or clarification with respect to other sections of the NDA.
“In anticipation of a not approvable letter from the FDA, in July we announced our intent to amend the current NDA with additional survival data,” states Timothy P. Walbert, president and CEO. “While the FDA has asked for data from additional clinical trials, we believe that this decision was made in context of the lack of complete data in the submitted NDA and that capturing supplemental data will overcome the need for additional trials and further confirm the overall survival benefit of L-MTP-PE in osteosarcoma.”
IDM Pharma says that it will collect vital status on patients who participated in the Phase III trial and for whom complete data were not available at the time of NDA filing in October 2006. The company expects to submit an amendment to the NDA by the first quarter of 2008.