Posted by Michael Wonder on 28 Jun 2018
Alexion submits application for approval of ALXN1210 as a treatment for patients with paroxysmal nocturnal haemoglobinuria in the European Union
28 June 2018 - EU filing follows U.S. filing in June 2018.
Alexion Pharmaceuticals today announced the submission of a marketing authorisation application to the EMA for ALXN1210, the Company’s investigational long-acting C5 complement inhibitor, for the treatment of patients with paroxysmal nocturnal haemoglobinuria (PNH). The application is supported by comprehensive data from two rigorous Phase 3 clinical trials in the largest population of patients with PNH ever studied in Phase 3: more than 440 patients, which included patients who had never received a complement inhibitor, and patients who were stable on Soliris (eculizumab) and switched to ALXN1210.
In two rigorous and large Phase 3 clinical studies, treatment with weight-based dosing of ALXN1210 every eight weeks demonstrated non-inferior results to treatment every two weeks with Soliris on all 11 primary and key secondary endpoints in both studies.
