Adventrx Pharmaceuticals, Inc. announced that the US Food and Drug Administration (FDA) has established a Prescription Drug User Fee Act (PDUFA) date of September 1, 2011 for the review of the Exelbine (ANX-530) New Drug Application (NDA). The acceptance of the Exelbine NDA is the FDA's determination that the application is sufficiently complete to permit a substantive review, and the PDUFA date is the goal date for the FDA to complete its review of the NDA.
“With a September PDUFA date established in the day 74 letter from the FDA, we look forward to working closely with the Agency on moving Exelbine toward approval this year,” said Brian M. Culley, chief executive officer of Adventrx.
Adventrx is seeking approval of Exelbine for the same indications as Navelbine, a branded formulation of vinorelbine, including non-small cell lung cancer. Adventrx submitted the NDA as a 505(b)(2) application that relies in part on the FDA's findings of safety and effectiveness of a reference drug. The Exelbine NDA includes data from one clinical bioequivalence study designed to assess the pharmacokinetic equivalence of Exelbine and Navelbine, the reference drug. In this clinical bioequivalence study, Exelbine and the reference drug were determined by Adventrx to be bioequivalent.
Adventrx retains exclusive worldwide rights to Exelbine, other than in South Korea, China, Hong Kong, Macau and Taiwan. In March 2010, the FDA conditionally accepted “Exelbine” as the proposed proprietary name for ANX-530. The United States Patent and Trademark Office has allowed patent claims related to Exelbine, which claims issued in January 2011 and will expire in November 2027.
Adventrx Pharmaceuticals is a specialty pharmaceutical company whose product candidates are being developed to improve the performance of existing anti-cancer drugs by addressing limitations associated principally with their safety and use.