Summary
Regeneron Pharmaceuticals, Inc. (REGN) announced on August 16, 2011, that the U.S. Food and Drug Administration (FDA) has extended the target completion date for its priority review of the Biologics License Application (BLA) for EYLEA™ (aflibercept injection). The new target date for the FDA's decision is November 18, 2011. This extension indicates that the FDA requires additional time to thoroughly review the BLA for EYLEA, a treatment for neovascular age-related macular degeneration. While an extended review period can sometimes signal potential concerns, it also reflects the FDA's commitment to a comprehensive assessment, especially for a priority drug. Investors should monitor further communications and the ultimate FDA decision on November 18, 2011.
Key Highlights
- 1FDA has extended the target review date for EYLEA's BLA to November 18, 2011.
- 2The application is for EYLEA™ (aflibercept injection) for the treatment of neovascular age-related macular degeneration.
- 3The FDA is conducting a priority review of the EYLEA BLA.
- 4The extension suggests the FDA needs more time for its comprehensive assessment.
- 5The original target date for the FDA's decision has been moved.