Alexion secures second source as site gets FDA approval

The FDA has approved Alexion Pharmaceuticals’ Rhode Island, US plant for commercial supply of Soliris (eculizumab), giving the biopharm a second source.

Approval by the US Food and Drug Administration (FDA) gives Alexion a second source of Soliris. Relying on one source can lead to drug shortages if manufacturing difficulties occur.

Genzyme highlighted this risk when Cerezyme (imiglucerase) and Fabrazyme (agalsidase beta) faced manufacturing problems. Alexion has sought to mitigate the threat by getting a second source approved, first by the European Medicines Agency (EMA) and now the FDA.

Gareth Thomas With both approvals in place Alexion has two sources, the Rhode Island plant and Lonza, which can meet all forecasted commercial and clinical needs in the US and Europe. In 2009, the US and Europe accounted for more than 90 per cent of revenues.

Stephen Squinto, executive vice president and head of research and development at Alexion, said: "Since before the launch of Soliris in 2007, we recognised the critical importance of ensuring the continuity of treatment for patients with ultra-rare and life-threatening diseases.”

Ultra-rare disorders

Soliris is the only drug specifically indicated for treatment of paroxysmal nocturnal hemoglobinuria (PNH), an ultra-rare, debilitating and life-threatening blood disorder. Consequently, disruptions to manufacturing or distribution could result in patients being unable to access treatments.

"Uninterrupted world-wide supply of Soliris provides patients with continued access to stable treatment regimens, and also supports our growing clinical development programs", said Squinto.

Alexion is trying to increase use of Soliris by gaining regulatory approval in other countries, such as Japan, and demonstrating its efficacy against other indications. A number of clinical trials are underway to investigate the use of Soliris in treating other severe and ultra-rare disorders.

Indications covered by the clinical trials include atypical hemolytic uremic syndrome (aHUS) and transplant patients at elevated risk of antibody-mediated graft rejection.

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