林业发展局批准EMPAVELI治疗稀有肾病,标志着C3G和IC-MPGN的首次治疗。 FDA approves EMPAVELI for rare kidney diseases, marking first treatment for C3G and IC-MPGN.

林业发展局已经批准Apellis制药公司(Peallis Petrogals)将EMPAVELI(pegcetacoplan)作为治疗罕见肾病的首例治疗,治疗12岁以上病人的C3球球病(C3G)和IC-MPGN初级治疗。 The FDA has approved EMPAVELI (pegcetacoplan) by Apellis Pharmaceuticals as the first treatment for rare kidney diseases C3 glomerulopathy (C3G) and primary IC-MPGN in patients aged 12 and older. 治疗表明,在第三阶段研究中,蛋白质尿和肾功能稳定减少了68%。 The treatment showed a 68% reduction in proteinuria and stabilization of kidney function in a Phase 3 study. 它是针对患有这些疾病和移植后复发的成年人和青少年的。 It is intended for adults and adolescents with these diseases and post-transplant recurrence. 安全概况有2 200多个病人年的数据支持。 The safety profile is supported by over 2,200 patient years of data.