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.

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 ...

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 ...

Apellis is also angling its Sobi-partnered C3 inhibitor Empaveli (pegcetacoplan) for a C3G nod. And by analysts’ observations, Apellis has better efficacy data. In the phase 3 Valiant trial ...

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 ...

The label comes with a few important restrictions/caveats that leave room for Apellis’s (APLS) Empaveli to differentiate itself. The firm highlights that Fabhalta is indicated for adults with ...

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 ...