ADVENTRX Pharmaceuticals, Inc. has received a refuse to file letter from the (FDA) regarding its New Drug Application (NDA) for ANX-530 (vinorelbine injectable emulsion). In the letter, the FDA indicated that the data included in the initial submission from the intended commercial manufacturing site was insufficient to support a commercially-viable expiration dating period. FDA identified only the one chemistry, manufacturing and controls (CMC) reason for the refusal to file. ADVENTRX plans to meet with the FDA as soon as possible to discuss its response.
To support a commercially-viable expiration dating period, the stability data provided in the ANX-530 NDA met ICH filing requirements for a new drug. Site-specific stability data from lots manufactured at the intended commercial manufacturing site also were submitted in the NDA.
"We believed, following discussions with the FDA at a pre-NDA meeting, the stability data package included in our initial submission supported both NDA acceptance and appropriate expiration dating. However, we now expect FDA will require additional site-specific stability data to accept our application. Although we plan to discuss the particular filing requirements with the reviewing chemists, site-specific stability studies are already ongoing and our recent financings provide us the capital to continue this work and, we expect, resubmit the application," said Brian M. Culley, Chief Executive Officer at ADVENTRX.
"We will work closely with the Agency to understand its new requirements and define the path to a successful resubmission at the earliest possible time," Mr. Culley continued.
ADVENTRX submitted the NDA for ANX-530 on December 30, 2009. Based on current regulations, once an NDA is submitted to the FDA, FDA has 60 days to preliminarily review the NDA submission and assess whether the NDA is sufficiently complete to permit a substantive review. If it determines that the NDA is not sufficiently complete, the FDA issues a refuse to file letter to the applicant. ADVENTRX plans to request a meeting with the FDA as soon as possible to discuss its comments on the NDA submission and to reach an understanding on what would be required for the ANX-530 NDA to be accepted for review.