8-KOther EventsExhibits & Filings

REGENERON PHARMACEUTICALS, INC. 8-K Report, Corporate Update (Apr 18, 2011)

Filed April 18, 2011For Securities:REGN

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.

Frequently Asked Questions

VEGF Trap-Eye is a drug developed by Regeneron Pharmaceuticals, Inc. that is intended for the treatment of the neovascular form of age-related macular degeneration (wet AMD).

A Priority Review designation by the FDA means that the agency will take action on the BLA within six months, rather than the standard 10 months. This designation is given to drugs that, if approved, may offer significant improvements in the safety and effectiveness of the treatment of a serious illness.

The acceptance of the Biologics License Application (BLA) by the FDA signifies that the agency has deemed the submitted application complete and ready for a substantive review. This is a critical step in the drug approval process, moving the drug closer to potential market availability.