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Alexion Submits MAA For ALXN1210 To European Medicines Agency - Quick Facts

Alexion Pharmaceuticals, Inc. (ALXN) announced Thursday the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for ALXN1210, its investigational long-acting C5 complement inhibitor, for the treatment of patients with paroxysmal nocturnal hemoglobinuria (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.

PNH is a chronic, progressive, debilitating, and potentially life-threatening ultra-rare blood disorder that can strike men and women of all races, backgrounds, and ages without warning, with an average age of onset in the early 30s.

Alexion had in mid-June submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for approval of ALXN1210 for the treatment of patients with PNH.

ALXN1210 has already received Orphan Drug Designation (ODD) for the treatment of patients with PNH in the U.S. and EU, and for the subcutaneous treatment of patients with atypical hemolytic uremic syndrome (aHUS) in the U.S.

Alexion is also preparing a submission for a New Drug Application for ALXN1210 as a treatment for patients with PNH in Japan in the second half of the year.

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