Apellis Pharmaceuticals has announced US FDA acceptance of the supplemental new drug application (sNDA) and the granting of priority review status to Empaveli (pegcetacoplan) to treat the rare and ...

Apellis' Empaveli currently competes with NVS’ Fabhalta for the PNH indication, and this competition is expected to intensify if Empaveli receives approval for the C3G indication.

EMPAVELI's unique mechanism of targeting C3 broadens its applicability beyond PNH, including other complement-driven diseases like geographic atrophy and immune complex-mediated diseases.

Empaveli (pegcetacoplan) is a prescription drug that treats paroxysmal nocturnal hemoglobinuria (PNH) by preventing the destruction of red blood cells in your blood vessels, liver, and spleen.

The FDA granted Priority Review to Apellis' sNDA for Empaveli in C3G and IC-MPGN, with a PDUFA target action date of July 28, 2025. Phase 3 results showed Empaveli reduced proteinuria by 68% and ...

In its approved use in PNH, Fabhalta already competes with Empaveli, a twice-weekly infusion from Apellis Pharmaceuticals that blocks the complement system protein C3. The two drugs could also ...

The Prescription Drug User Fee Act, PDUFA, target action date is July 28, 2025. “EMPAVELI demonstrated clinically meaningful benefits across all three key markers of disease – unprecedented ...

Apellis Pharmaceuticals APLS announced that the FDA has accepted its supplemental new drug application (sNDA) seeking the label expansion of Empaveli (pegcetacoplan) for two rare and severe ...

EMPAVELI's unique mechanism of targeting C3 broadens its applicability beyond PNH, including other complement-driven diseases like geographic atrophy and immune complex-mediated diseases. With a high ...