Regeneron Reports the US FDA’s Acceptance of sBLA for Priority Review of Eylea to Treat Retinopathy of Prematurity
Shots:
- The US FDA has accepted the sBLA of Eylea for Priority Review to treat ROP in preterm infants. The US FDA’s decision is expected on Feb 11, 2023
- The sBLA was based on the 2 P-III (FIREFLEYE) & (BUTTERFLEYE) trial evaluating Eylea (0.4mg) vs laser in 113 & 120 infants which showed that ~80% achieved an absence of active ROP and unfavorable structural outcomes @52wk. The trials failed to meet the 1EPs of non-inferiority due to laser photocoagulation achieving comparable levels of efficacy higher than prior observed in similar ROP trials
- In an exploratory analysis, time to complete treatment administration (4 vs 122min.) & (11 vs 129min.) with no new safety signals, 39% vs 37% AEs in (FIREFLEYE) & 18% vs 26% in (BUTTERFLEYE)
Ref: PRNewswire | Image: Regeneron
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