Article
FDA accepts Regeneron’s aflibercept injection submission for review
Author(s):
The FDA has accepted the supplemental Biologics License Application of aflibercept injection for review in patients with diabetic retinopathy.
The FDA has accepted Regeneron Pharmaceuticals’ supplemental Biologics License Application (sBLA) of aflibercept (Eylea) injection for review in patients with diabetic retinopathy (DR).
According to a news release from the company, the regulatory agency has set a target action date of February 28, 2023.
Regeneron noted that the supplemental Biologics License Application (sBLA) is supported by data readout from the Phase 3 PANORAMA trial investigating every 8- and 16-week aflibercept dosing regimens, versus sham, in patients with severe non-proliferative diabetic retinopathy (NPDR) without diabetic macular edema (DME).
Additionally, the filing was further supported by clinical data from the NIH-sponsored Protocol W trial evaluating an aflibercept every 16-week dosing regimen in patients with moderate to severe NPDR without center-involved DME versus sham.
If approved by the regulators, the aflibercept every 16-week dosing regimen could offer certain patients a potentially longer treatment interval and doctors with greater flexibility to individualize treatment.
