IDM Pharma Provides Update on Mifamurtide (L-MTP-PE) Regulatory Status Following September Meeting of European Committee for Medicinal Products for Human Use (CHMP)
Based on discussions at that meeting, the Company has been invited topresent to the CHMP Scientific Advisory Group on Oncology (SAG-O) and to theCHMP to review and address the remaining open issues in its MAA for L-MTP-PE.These meetings are scheduled to take place in November. The SAG-O is regularlyconvened at the request of the CHMP to provide independent advice onscientific/technical matters relating to oncology products under evaluation bythe CHMP, or on any other scientific issue relevant to the work of the CHMPthat relates to this area. The Company will provide SAG-O and CHMP informationto address the remaining open issues in advance of these meetings.
"The European review of L-MTP-PE continues to progress," said Timothy P.Walbert, president and chief executive officer, IDM Pharma. "We are pleased toreport that, in response to the comprehensive information we submitted inadvance of the September CHMP meeting, the CHMP has determined that theChildren's Oncology Group's (COG) Phase 3 trial is compliant with GoodClinical Practices (GCP) and that the database from this pivotal study can bereliably used in the evaluation process of the MAA. We also received feedbackfrom the CHMP that there are no major objections remaining related tochemistry, manufacturing and controls (CMC)."
Mr. Walbert continued, "While we have satisfactorily addressed issuesrelated to the positive benefit/risk assessment reached at the oralexplanation meeting with the CHMP in January 2008, we have been invited by theCHMP to meet with SAG-O and CHMP in November to address certain open issuesarising from the assessment by the Rapporteur and Co-Rapporteur. We welcomethe opportunity to present to both the SAG-O and CHMP to complete the L-MTP-PEMAA review and we remain confident that L-MTP-PE provides a significantoverall survival benefit for osteosarcoma patients and meets an importantunmet treatment need."
With the final CHMP opinion now anticipated in November, IDM Pharmaexpects a final decision from the European Commission in the first quarter of2009. If approved for Marketing Authorization by the European Commission,L-MTP-PE will be the first treatment in more than 20 years approved forpatients with osteosarcoma.
In January 2008, the Company announced that, following presentation ofdata at an oral explanation hearing, the CHMP determined in a non-bindingopinion that L-MTP-PE suggested a possible clinical benefit in terms ofsurvival and granted the Company a clock-stop, or time extension to allow IDMPharma additional time to respond to questions regarding the MAA. At thattime, the CHMP requested clarification of the existing data in order to gainassurance about the quality of the data before drawing any final conclusionsfrom the data presented. In addition, the Company was required to address anumber of remaining questions relating to CMC.
In April 2008, the European regulatory authorities conducted an inspectionof the COG to assess the quality of the overall survival data from the 2006confirmatory database included in the Company's applications for regulatoryapproval, and to review GCP compliance of the COG in terms of patientrandomization and stratification, overall survival data collection, and studymonitoring. The Company supported the COG in this effort.
Following the satisfactory GCP inspection in April a
You May Also Like