Apellis Pharmaceuticals Inc. has announced the FDA approval of EMPAVELI® (pegcetacoplan) for the treatment of C3G and primary IC-MPGN in patients aged 12 and older. This approval marks a significant milestone as EMPAVELI is now the first treatment option for these rare kidney diseases, which carry a high risk of kidney failure. The decision was based on positive results from the VALIANT study, showcasing a 68% reduction in proteinuria and stabilization of kidney function. The broad label includes adults and adolescents, as well as post-transplant C3G disease recurrence cases. Apellis will host a conference call on July 29, 2025, to discuss this landmark approval further.
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