Apellis Pharma Secures FDA Approval For EMPAVELI To Treat Rare Kidney Disorders

(RTTNews) - Apellis Pharmaceuticals Inc. (APLS) announced that the U.S. Food and Drug Administration has approved EMPAVELI (pegcetacoplan) as the first treatment for C3 glomerulopathy (C3G) or primary immune complex membranoproliferative glomerulonephritis (IC-MPGN) in patients 12 years of age and older, to reduce proteinuria. C3G and primary IC-MPGN are rare kidney diseases, affecting 5,000 people in the United States.

The approval of EMPAVELI is based on positive six-month results from the VALIANT study, demonstrating benefits across all three key markers of disease.

The most common adverse reactions in the VALIANT study (10%) were infusion site reactions, pyrexia, nasopharyngitis, influenza, cough, and nausea.

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