Posted by Michael Wonder on 15 May 2021
Apellis announces U.S. FDA approval of Empaveli (pegcetacoplan) for adults with paroxysmal nocturnal hemoglobinuria
14 May 2021 - Empaveli was superior to Soliris for the change from baseline in haemoglobin level at Week 16 in the Phase 3 PEGASUS trial.
Apellis Pharmaceuticals today announced that the U.S. FDA has approved Empaveli (pegcetacoplan), the first and only targeted C3 therapy for treatment of adults with paroxysmal nocturnal hemoglobinuria.
Empaveli is approved for use in adults with paroxysmal nocturnal hemoglobinuria who are treatment naïve as well as patients switching from the C5 inhibitors Soliris (eculizumab) and Ultomiris (ravulizumab).
