Alexion's Soliris gets approval in Japan for rare disorder

The Ministry of Health, Labor and Welfare (MHLW) in Japan has approved Soliris (eculizumab) from US drugmaker Alexion Pharmaceuticals (Nasdaq: ALXN) for the treatment of pediatric and adult patients with atypical hemolytic uremic syndrome (aHUS), a life-threatening ultra-rare disorder.

Soliris is already approved in Japan for paroxysmal nocturnal hemoglobinuria (PNH), another severe and ultra-rare disease. Alexion expects that initial patients with aHUS in Japan will commence treatment with Soliris by the end of this year. Globally, the drug generated sales of just over $370 million in the second quarter of 2013, a year-on-year rise of 35%.

David Hallal, executive vice president and chief commercial officer of Alexion, said: “The approval of Soliris for the treatment of aHUS by the Japanese government brings life-transforming hope to patients suffering from this devastating disease. We will initiate our disease awareness and education programs as we work closely with the healthcare community to support rapid and accurate diagnosis of aHUS as well as better informed treatment decisions.”