Posted by Michael Wonder on 15 Sep 2020
Apellis announces submission of pegcetacoplan marketing applications to FDA and EMA for patients with PNH
15 September 2020 - -- Apellis Pharmaceuticals today announced that the company has submitted a new drug application to the U.S. FDA and a narketing authorisation application to the EMA for pegcetacoplan for the treatment of paroxysmal nocturnal haemoglobinuria in the United States and European Union, respectively.
The submissions are based on results from the Phase 3 PEGASUS trial, which met its primary outcome, demonstrating the superiority of pegcetacoplan to eculizumab with a statistically significant improvement in haemoglobin levels at 16 weeks, as well as higher normalisation rates across key markers of haemolysis and clinically meaningful improvement in FACIT-fatigue score.
