Apellis Pharmaceuticals (APLS) said Tuesday that the US Food and Drug Administration has accepted its supplemental new drug application for Empaveli, or pegcetacoplan, to treat C3 glomerulopathy and primary immune complex membranoproliferative glomerulonephritis, both rare kidney diseases.
The company said the application is based on results from a late-stage trial that achieved its primary endpoint of "statistically significant" reduction in proteinuria and indicated stabilization of kidney function in patients treated with Empaveli.
The agency granted the application Priority Review and scheduled a decision date of July 28, Apellis said.
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