Regeneron gets FDA nod for updated Eylea label
Regeneron Pharmaceuticals has received the green light from the Food and Drug Administration for a supplemental Biologics License Application for Eylea (aflibercept) injection in patients with wet age-related macular degeneration, or wet AMD.
The sBLA was based on second-year data from the Phase 3 View 1 and 2 trials in which patients with wet AMD were treated with a modified 12-week dosing schedule — doses given at least every 12 weeks, and additional doses as needed. These data are now included in the updated Eylea label, according to the company.
"We are pleased that the FDA has approved an updated label for Eylea," Regeneron president and chief scientific officer George Yancopoulos said in a press statement. "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."
Eylea also is approved in wet AMD for every four- or eight-week dosing intervals after three initial monthly doses.
The product is a vascular endothelial growth factor inhibitor formulated as an injection for the eye. It is designed to block the growth of new blood vessels and decrease the ability of fluid to pass through blood vessels in the eye by blocking VEGF-A and placental growth factor, two growth factors involved in angiogenesis.
The sBLA was based on second-year data from the Phase 3 View 1 and 2 trials in which patients with wet AMD were treated with a modified 12-week dosing schedule — doses given at least every 12 weeks, and additional doses as needed. These data are now included in the updated Eylea label, according to the company.
"We are pleased that the FDA has approved an updated label for Eylea," Regeneron president and chief scientific officer George Yancopoulos said in a press statement. "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."
Eylea also is approved in wet AMD for every four- or eight-week dosing intervals after three initial monthly doses.
The product is a vascular endothelial growth factor inhibitor formulated as an injection for the eye. It is designed to block the growth of new blood vessels and decrease the ability of fluid to pass through blood vessels in the eye by blocking VEGF-A and placental growth factor, two growth factors involved in angiogenesis.