FDA Approves Apellis’ EMPAVELI® (Pegcetacoplan) as the First C3G and Primary IC-MPGN Treatment for Patients 12 and Older

FDA Approves Apellis’ EMPAVELI® (pegcetacoplan) as the First C3G and Primary IC-MPGN Treatment for Patients 12 and Older

Proven efficacy across all three key markers of disease—68% reduction in proteinuria, stabilization of kidney function, and substantial clearance of C3...

FDA Approves Apellis' EMPAVELI® (pegcetacoplan) as the First C3G and Primary IC-MPGN Treatment for Patients 12 and Older - Apellis Pharmaceuticals (NASDAQ:APLS)

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FDA Approves Empaveli for Two Rare Kidney Diseases

C3 glomerulopathy (C3G) and immune-complex membranoproliferative glomerulonephritis (IC-MPGN) are two diseases that have a high risk of kidney failure. Empaveli is also approved to treat patients with paroxysmal nocturnal hemoglobinuria.

Everything You Need to Know About C3G and IC-MPGN

Medically reviewed by David Ozeri, MDC3G (Complement 3 Glomerulopathy) and IC-MPGN (Immune Complex Membranoproliferative Glomerulonephritis) are rare, incurable kidney diseases that have similar symptoms and progression. While these diseases have many common traits, they are recognized as distinct disorders due to different underlying causes and mechanisms.Jump to Key Takeaways.Morsa Images / Getty ImagesWhat Are C3G and IC-MPGN?C3G and IC-MPGN …

FDA approves pegcetacoplan as first treatment for C3 glomerulopathy or IC-MPGN

Pegcetacoplan (Empaveli: Apellis PHarmaceuticals) is indicated for patients aged 12 years and older to reduce proteinuria.

Apellis and Sobi’s Empaveli clinches FDA approval for rare kidney diseases

Apellis Pharmaceuticals and Sobi’s Empaveli secured an FDA label expansion for two kidney diseases on Monday, opening up a market of around 5,000 patients in the US. The FDA approved the ...