Novartis Nabs First FDA Nod in Rare Kidney Disease, But Apellis Pharma Is on Its Heels

MedCity News March 23, 2025
Frank Vinluan

Novartis’s Fabhalta is the first FDA-approved therapy for C3 glomerulopathy. But Apellis Pharmaceuticals’ Empaveli has superior clinical data, and that drug has been submitted for FDA review in the same rare kidney disease as well as another one that does not yet have an approved therapy.

An ultra-rare kidney disease that can become life-threatening now has its first FDA-approved therapy. The affirmative regulatory decision is the third for Novartis’s Fabhalta, building up the drug’s pipeline-in-a-product potential. But competition looms from a rival drug taking a similar approach.

The March 20 approval of Fabhalta covers the treatment of adults with C3 glomerulopathy (C3G), a disease affecting glomeruli, tiny blood vessels in the kidney responsible for filtering waste from the blood. C3G...

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