Research & Development
Regeneron Pharmaceuticals Inc passes US FDA approval for EYLEA (aflibercept) Injection sBLA in wet AMD
20 August 2018 -

Biotechnology company Regeneron Pharmaceuticals Inc (NASDAQ:REGN) disclosed on Friday the receipt of the US Food and Drug Administration (FDA) approval for a supplemental Biologics License Application (sBLA) for EYLEA (aflibercept) Injection in patients with wet age-related macular degeneration (wet AMD).

The company said the sBLA was based on second-year data from the company's 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.

Additionally, EYLEA is approved in wet AMD for every four- or eight-week dosing intervals after three initial monthly doses, according to the company.

In conjunction, EYLEA (aflibercept) Injection is a vascular endothelial growth factor (VEGF) 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 (vascular permeability) in the eye by blocking VEGF-A and placental growth factor (PLGF), two growth factors involved in angiogenesis.

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