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The FDA has approved pegcetacoplan (Empaveli, Apellis Pharmaceuticals, Inc.) for the treatment of C3 glomerulopathy (C3G) or primary immune complex membranoproliferative glomerulonephritis (IC-MPGN) in patients aged 12 years and older.
C3G and primary IC-MPGN are rare kidney diseases affecting approximately 5000 people in the US, particularly adolescents or young adults. They often lead to kidney failure requiring dialysis or kidney transplant.
In the recently released Phase 3 VALIAN Trial 52-week results, patients receiving pegcetacoplan achieved and maintained a significant reduction in proteinuria over baseline, with a mean urine protein-to-creatinine ratio change at week 26 of -68.1% and at week 52 of -67.2%.
In addition, the pegcetacoplan group showed reductions in levels of the estimated glomerular filtration rate of 1.2 mL/min/1.73 m2 at week 26 and 3.7 mL/min/1.73 m2 at week 52.
The most common adverse reactions were infusion-site reactions, pyrexia, nasopharyngitis, influenza, cough, and nausea, according to a company press release.
The product will carry a black box warning stating, “Empaveli, a complement inhibitor, increases the risk of serious infections, especially those caused by encapsulated bacteria, such as Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae type B.”
“Because of the risk of serious infections caused by encapsulated bacteria, Empaveli is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the EMPAVELI REMS.”
Kathleen Dallessio is the Senior Editor for Diabetes & Endocrinology and Nephrology at Medscape Medical News.
