A Phase 3, Randomized, Open-Label, Active-Controlled Study of ALXN1210 Versus Eculizumab in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Eculizumab
Active, no longer recruiting
Phase of Trial: Phase III
Latest Information Update: 01 Aug 2018
At a glance
- Drugs Ravulizumab (Primary) ; Eculizumab
- Indications Paroxysmal nocturnal haemoglobinuria
- Focus Registrational; Therapeutic Use
- Sponsors Alexion Pharmaceuticals
- 28 Jun 2018 According to an Alexion Pharmaceuticals media release, company announced the submission of a Marketing Authorization Application to the European Medicines Agency (EMA) for ALXN1210, the Company's investigational long-acting C5 complement inhibitor, for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH), based on data from this trial and CTP- 700277981.
- 19 Jun 2018 According to an Alexion Pharmaceuticals media release, company announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for approval of ALXN1210 for the treatment of patients with paroxysmal nocturnal hemoglobinuria, based on the data from this study. The submission uses a rare disease priority review voucher, which designates the BLA for an expedited eight-month review by the FDA instead of the standard 12-month review.
- 26 Apr 2018 According to an Alexion Pharmaceuticals media release, detailed results from this study will be presented at a future medical congress.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History