Summary
Regeneron Pharmaceuticals, Inc. announced on April 18, 2011, that the U.S. Food and Drug Administration (FDA) has accepted for review their Biologics License Application (BLA) for VEGF Trap-Eye. This drug is intended for the treatment of the neovascular form of age-related macular degeneration (AMD), commonly known as wet AMD. Crucially, the FDA has also granted Regeneron's request for priority review of this BLA. A priority review designation is granted to applications for drugs that, if approved, would offer a significant improvement in the safety or effectiveness of the treatment, diagnosis, or prevention of a serious condition. This suggests the FDA recognizes the potential of VEGF Trap-Eye to address a significant unmet medical need in wet AMD patients.
Key Highlights
- 1FDA has accepted the Biologics License Application (BLA) for VEGF Trap-Eye.
- 2VEGF Trap-Eye is intended for the treatment of neovascular (wet) age-related macular degeneration (AMD).
- 3FDA granted Regeneron's request for Priority Review of the BLA.
- 4Priority Review designation indicates a potential for significant improvement in treatment of a serious condition.
- 5This filing signifies a key regulatory milestone in the development of VEGF Trap-Eye.