Alexion Pharmaceuticals, Inc. and Alexion Pharma International Sàrl received approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) for the use of Soliris (eculizumab) as a treatment for patients in Japan with paroxysmal nocturnal hemoglobinuria (PNH). PNH is a rare, debilitating and life-threatening blood disorder defined by chronic red blood cell destruction, or hemolysis. Soliris, a terminal complement inhibitor, is the first therapy approved in Japan for the treatment of PNH. Soliris received orphan drug designation from the MHLW in 2009 and was approved under the Ministry’s priority review process.

“The speedy approval of the Soliris NDA in Japan underscores the severity of PNH in Japanese patients and the significant clinical impact that this treatment provides to patients living with PNH,” said Leonard Bell, M.D., chief executive officer of Alexion. “This regulatory approval marks another important step in our global commitment to the objective of providing access to Soliris to all patients who can benefit from it. We now look forward to working closely with the healthcare authorities in Japan to make Soliris available to patients as rapidly as possible.”

Soliris was approved as a treatment for patients with PNH by FDA and the European Commission in 2007, and has since received similar approvals in other countries, including Australia, Korea and Canada.