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 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 kidney ...

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.

Pharmaceuticals announced that the U.S. Food and Drug Administration, FDA, has accepted and granted Priority Review designation ...

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 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 ...

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.

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 ...