Apellis wins US approval for Empaveli in rare kidney diseases
Apellis Pharmaceuticals (Nasdaq: APLS) has received clearance from the American medicines regulator for Empaveli (pegcetacoplan) as the first treatment to reduce proteinuria in patients aged 12 and older with C3 glomerulopathy (C3G) or primary immune complex membranoproliferative glomerulonephritis (IC-MPGN).
The approval is based on the Phase III VALIANT study, where Empaveli achieved a 68% reduction in proteinuria versus placebo and showed stabilization of kidney function. The trial also demonstrated a majority of patients experienced a reduction in C3 deposits, with 71% reaching complete clearance.
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