Millennium Pharmaceuticals Inc announced that the U.S. Food and Drug Administration (FDA) accepted for review and granted Priority Review designation of the Company's New Drug Application (NDA) for Velcade for the treatment of relapsed and refractory multiple myeloma. Priority Review is granted by the FDA to an NDA for a new treatment that addresses an unmet medical need. The FDA expedites the approval process for such an NDA by reducing the target review period for the application from 10 months to six months. Acceptance of the filing means that FDA has made a threshold determination that the NDA is sufficiently complete to permit a substantive review.
"We believe that the acceptance of our NDA for review is another step in our ongoing commitment of working to get this important medicine to multiple myeloma patients," said Barry Greene, general manager, oncology at Millennium. "The Agency's decision to grant the application Priority Review status underscores the potential therapeutic benefit of Velcade and represents a significant step toward the Company's global mission of developing novel treatments in areas of significant unmet medical need."
The acceptance of this filing comes approximately six weeks after the Company filed marketing applications in both the U.S. and the European Union (EU). VELCADE was granted fast track status by the FDA in June 2002, and Millennium filed the NDA under the provisions of Subpart H Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses on January 21, 2003. The Agency for the Evaluation of Medicinal Products (EMEA) accepted the Marketing Authorization Application (MAA) for review on February 24, 2003.
The NDA submission was based primarily upon the results of the phase II SUMMIT trial, a multi-center study of 202 patents with relapsed and refractory multiple myeloma which were presented in full at the December 2002 meeting of the American Society of Hematology (ASH). The data were submitted electronically as well as in the common technical document (CTD) format, which allowed for nearly simultaneous filings in the U.S. and the EU.