Alexion Pharmaceuticals’ Rhode Island manufacturing facility (ARIMF) in Smithfield has been approved by the FDA as a second source of commercial supply for Soliris. The EMA had approved ARIMF as a second source of supply for Soliris in the EU earlier this year. The company will maintain its agreement with its long-time contract manufacturer and, through either source, can now meet all of the forecasted commercial and clinical needs for Soliris. Additionally, Alexion has applied for regulatory approvals for ARIMF in other countries where it has, or is establishing, commercial operations.
Soliris is the only drug specifically indicated for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH), an ultra-rare, debilitating and life-threatening blood disorder. Soliris was approved in the U.S. and EU in 2007, as well as by the regulatory authorities of other countries, including Japan's Ministry of Health, Labour and Welfare (MHLW) in 2010. Also, more than a dozen clinical studies of Soliris as a treatment for other severe and rare disorders are currently underway in areas that include nephrology and transplant.
“Since before the launch of Soliris in 2007, we recognized the critical importance of ensuring the continuity of treatment for patients with ultra-rare and life-threatening diseases,” said Stephen P. Squinto, executive vice president and head of R&D at Alexion. “Uninterrupted world-wide supply of Soliris provides patients with continued access to stable treatment regimens, and also supports our growing clinical development programs.”