Apellis’ Empaveli Gains FDA Approval for Broad C3 Glomerulopathy Use, Setting Up Competition with Novartis’ Fabhalta

The FDA approved Apellis Pharmaceuticals' Empaveli (pegcetacoplan) on July 28, 2025, for the treatment of C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN) in patients aged 12 and older13.

Empaveli is now the first approved treatment for both C3G and primary IC-MPGN in this age group, addressing rare kidney diseases that often progress to kidney failure and affect around 5,000 individuals in the U.S.13.

Approval was based on Phase 3 trial data showing a 68% reduction in proteinuria and stabilization of kidney function compared to placebo, with a well-established safety profile across over 2,200 patient-years13.

The Empaveli label is broader than that for Novartis' oral Fabhalta (iptacopan), which was approved earlier in 2025 but only for adults and does not include data for post-transplant patients23.

Empaveli’s approved indication includes adolescents, adults, and post-transplant recurrence, while Fabhalta’s FDA label is adult-only2.

A potential competitive advantage for Fabhalta is its oral administration route, while Empaveli is administered via injection2.

Both companies are vying for the C3G market, but Apellis’ FDA nod offers a broader patient demographic and includes additional disease presentations23.

Sources:

1. https://www.morningstar.com/news/dow-jones/2025072810358/apellis-pharmaceuticals-gets-fda-approval-for-kidney-disease-treatment

2. https://www.fiercepharma.com/pharma/novartis-snags-fda-nod-fabhalta-another-kidney-disease-leaves-room-rival-apellis

3. https://www.globenewswire.com/news-release/2025/07/28/3122935/0/en/FDA-Approves-Apellis-EMPAVELI-pegcetacoplan-as-the-First-C3G-and-Primary-IC-MPGN-Treatment-for-Patients-12-and-Older.html