FDA approves new treatment for adults with serious rare blood …
WEBFDA has approved Empaveli (pegcetacoplan) injection to treat adults with paroxysmal nocturnal hemoglobinuria (PNH), a rare, life-threatening blood disease. Empaveli is the first PNH treatment...
Europe's CHMP turns down Apellis' pegcetacoplan appeal, …
WEB4 days ago · Pegcetacoplan was initially approved in the U.S. for the rare blood disorder paroxysmal nocturnal hemoglobinuria in 2022 under the brand name Syfovre. Syfovre subsequently won an FDA nod in GA in ...
Sobi and Apellis announce positive topline results from phase 3 …
WEBAug 8, 2024 · Pegcetacoplan is approved for the treatment of paroxysmal nocturnal haemoglobinuria (PNH) as EMPAVELI ® /Aspaveli ® in the United States, European Union, and other countries globally.
Apellis plans FDA filing after drug success in kidney trial
WEBAug 8, 2024 · The drug, called pegcetacoplan and sold by Apellis as Empaveli for a rare blood disorder, reduced urine protein levels by 68% versus placebo in people with either C3 glomerulopathy or primary immune complex membranoproliferative glomerulonephritis.
Pegcetacoplan versus Eculizumab in Paroxysmal Nocturnal …
WEBMar 17, 2021 · Pegcetacoplan was superior to eculizumab with respect to the change in hemoglobin level from baseline to week 16, with an adjusted (least squares) mean difference of 3.84 g per deciliter...
FDA Approves SYFOVRE™ (pegcetacoplan injection) as the First …
WEBFeb 17, 2023 · SYFOVRE™ (pegcetacoplan injection) is the first and only approved therapy for geographic atrophy (GA). By targeting C3, SYFOVRE is designed to provide comprehensive control of the complement cascade, part of the body’s immune system.
Apellis Announces FDA Acceptance and Priority Review of the
WEBJul 19, 2022 · Pegcetacoplan is an investigational, targeted C3 therapy for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The Prescription Drug User Fee Act...
Positive data from phase 2 NOBLE study of pegcetacoplan …
WEBMay 24, 2024 · Sobi® and Apellis Pharmaceuticals, Inc. today announced positive one-year results from the phase 2 NOBLE study investigating systemic pegcetacoplan, a targeted C3 therapy, for the treatment of...
SYFOVRE® (pegcetacoplan injection) Continued to Demonstrate …
WEBNov 4, 2023 · SYFOVRE ® (pegcetacoplan injection) is the first and only approved therapy for geographic atrophy (GA). By targeting C3, SYFOVRE is designed to provide comprehensive control of the complement cascade, part of the body’s immune system.
Long-Term Safety and Efficacy of Pegcetacoplan Treatment in …
WEBNov 15, 2022 · Pegcetacoplan (PEG) is the first approved C3 inhibitor for US adults with PNH and EU adults with PNH who are anemic after treatment with a C5 inhibitor for ≥3 months. In 5 clinical trials, PEG significantly improved hemoglobin (Hb) and other disease parameters in patients with PNH who were anemic, …
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