Summary
This 8-K filing from Regeneron Pharmaceuticals, Inc. reports a significant development concerning ZALTRAP® (aflibercept), a drug developed in collaboration with Sanofi. Sanofi has voluntarily withdrawn the Biologics License Application (BLA) submitted to the U.S. Food and Drug Administration (FDA) for marketing approval of ZALTRAP® in previously treated metastatic colorectal cancer. This withdrawal is planned to be followed by a re-submission in early 2012. The reason cited for the withdrawal pertains to comments received from the FDA regarding the Chemistry, Manufacturing, and Controls (CMC) section of the BLA. While this represents a delay in the approval timeline, it is important to note that the withdrawal is not based on efficacy or safety concerns of the drug itself, but rather on manufacturing and control aspects. Investors should monitor the re-submission process and the FDA's subsequent review.
Key Highlights
- 1Sanofi voluntarily withdrew the BLA for ZALTRAP® (aflibercept) with the FDA on December 19, 2011.
- 2The BLA was for marketing approval in previously treated metastatic colorectal cancer.
- 3Sanofi plans to re-submit the BLA in early 2012.
- 4The withdrawal was based on FDA comments concerning the Chemistry, Manufacturing, and Controls (CMC) section of the BLA.
- 5ZALTRAP® is being developed through a worldwide collaboration between Regeneron and Sanofi.
- 6The withdrawal is not related to the drug's efficacy or safety profile.