Apellis’ EMPAVELI Approved by FDA for Rare Kidney Diseases

Apellis Pharmaceuticals Inc. (NASDAQ:APLS) is one of the biotech stocks to buy according to Wall Street analysts. On July 29, Apellis announced that the US FDA 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.

This approval aims to reduce proteinuria in patients with these rare kidney diseases, which affect ~5,000 people in the US and ~8,000 in Europe. These conditions often lead to kidney failure within 5 to 10 years of diagnosis, and around 90% of kidney transplant patients with C3G experience disease recurrence. The approval is based on positive six-month results from the Phase 3 VALIANT study (NCT05067127), the largest single trial conducted in these patient populations, including both pediatric and adult patients with native and post-transplant kidneys.

A close-up of a hand holding a vial of biopharmaceutical drugs ready to be administered.

EMPAVELI demonstrated efficacy by meeting its primary endpoint with a 68% reduction in proteinuria compared to placebo. EMPAVELI is a targeted C3 therapy that works by regulating excessive activation of the complement cascade, a part of the body’s immune system.

Apellis Pharmaceuticals Inc. (NASDAQ:APLS) is a commercial-stage biopharmaceutical company that discovers, develops, and commercializes novel therapeutic compounds to treat diseases with high unmet needs.

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Disclosure: None. This article is originally published at Insider Monkey.