Apellis Reports the US FDA Acceptance and Priority Review of NDA for Pegcetacoplan to Treat Geographic Atrophy
Shots:
- The NDA submission was based on the P-III (DERBY) & (OAKS) studies in 621 & 637 patients at 12 & 18mos. and the P-II (FILLY) study in 246 patients at 12mos. evaluating the efficacy & safety of pegcetacoplan (IVT) in patients with GA secondary to AMD. The PDUFA action date is expected on Nov 26, 2022
- The results showed that treatment with both monthly & EOM pegcetacoplan resulted in a clinical reduction of GA lesion growth across a broad, heterogeneous population of 1500+ patients & demonstrated a favorable safety profile in all studies
- Patients in (DERBY) & (OAKS) study will continue to receive masked treatment for 24mos. The company plans to submit an MAA to the EMA for pegcetacoplan in H2'22
Ref: GlobalNewswire | Image: Organon
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