Apellis Pharmaceuticals Gets FDA Approval for Kidney Disease Treatment

Dow Jones

Jul 29, 2025

By Kelly Cloonan

Apellis Pharmaceuticals said it has received approval from the Food and Drug Administration for Empaveli, its treatment for rare kidney diseases.

The biopharmaceutical company said Monday that Empaveli is now the first treatment for C3 glomerulopathy and primary immune complex membranoproliferative glomerulonephritis in patients 12 years of age and older.

The diseases affect 5,000 people in the U.S., and frequently lead to kidney failure, the company said.

The treatment's approval is based on positive six-month results from the company's Phase 3 study, which found the treatment demonstrated a 68% reduction in proteinuria and stabilization of kidney function compared to a placebo.

"Empaveli has the potential to be truly transformational for patients with C3G and primary IC-MPGN, who until now have had very few treatment options," Chief Executive Cedric Francois said.

Write to Kelly Cloonan at kelly.cloonan@wsj.com

(END) Dow Jones Newswires

July 28, 2025 19:40 ET (23:40 GMT)

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