Alexion Submits Application for Approval of ALXN1210 as a Treatment for Patients with Paroxysmal Nocturnal Hemoglobinuria in the EU

Alexion Pharmaceuticals (NASDAQ:ALXN) 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).

As quoted in the press release:

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.

“We are excited about this next important step toward our goal of establishing ALXN1210 as the new standard of care for patients with PNH, following our recent submission in the U.S.,” said John Orloff, M.D., Executive Vice President and Head of Research & Development at Alexion. “Building on 10 years of proven efficacy and safety with Soliris®, and 25 years of leadership in complement biology, our Phase 3 studies enrolled a very broad patient population, representative of those with PNH in clinical practice, including patients with a history of aplastic anemia, ‘classic’ PNH, as well as transfused and non-transfused patients. We look forward to working with European regulators to facilitate a smooth review.”

Click here to read the full press release.