Regeneron’s supplemental biologics licence application for EYLEA gains FDA approval

The US Food and Drug Administration (FDA) has granted approval to Regeneron Pharmaceuticals for a supplemental biologics licence application (sBLA) for EYLEA (aflibercept) injection in patients with wet age-related macular degeneration (AMD).

“We are pleased that the FDA has approved an updated label for EYLEA,” stressed Dr George D. Yancopoulos, PhD, president and chief scientific officer of Regeneron. “Providing information to retinal physicians about the visual outcomes with a modified 12-week dosing schedule will help physicians make the most informed choices in treating patients suffering from wet age-related macular degeneration.”

The sBLA was based on second-year data from the Phase III VIEW 1 and 2 trials in which patients were administered with a modified 12-week dosing schedule — doses were given every 12 weeks with additional doses administered when necessary. Data from the clinical trials are now included in the updated product label.

Additionally, EYLEA is approved for use in the treatment of wet AMD at four or eight-week dosing intervals once the initial three-monthly doses have been administered.