FDA Grants Priority Review to Regeneron’s Eylea sBLA in Retinopathy of Prematurity
The FDA has granted Priority Review to Regeneron’s supplemental Biologics License Application (sBLA) for its blockbuster drug Eylea (aflibercept), as an injection in the proposed treatment for preterm infant patients who have retinopathy of prematurity, an eye disease that includes abnormal development of retinal blood vessels.
The sBLA is supported by data from two phase 3 trials. In both trials, approximately 80 percent of infants treated with Eylea achieved an absence of both active retinopathy of prematurity and unfavorable structural outcomes at 52 weeks of age. However, noninferiority was not established.
Eylea is FDA-approved for the treatment of patients with neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema and diabetic retinopathy.
The FDA’s target action date for this sBLA is Feb. 11, 2023.
October 13, 2022
