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news.Alexion Pharmaceuticals, a biopharmaceutical company, has announced that Health Canada has approved the use of Soliris for the treatment of all patients in Canada with paroxysmal nocturnal hemoglobinuria.
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Soliris is said to be the first therapy approved in Canada for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). Soliris was approved under priority review by Health Canada’s Biologics and Genetic Therapies Directorate (BGTD).
The marketing application submitted to the BGTD included safety and efficacy data from three multi-national clinical studies: Triumph, a placebo-controlled 26-week Phase III study involving 87 PNH patients, Shepherd, an open-label 52-week Phase III trial involving 97 PNH patients, and E05-001, a long term extension study.
Soliris was approved by the FDA and the European Commission in 2007 using data from the same studies and is currently being used to treat patients with PNH in the US and more than 15 additional countries.
Leonard Bell, CEO of Alexion, said: This approval paves the way for patients with PNH across Canada to begin receiving the clinical benefits of Soliris. We are currently developing our organization in Canada and we will now work with Canada’s public and private healthcare organizations to provide access to Soliris, patient-by-patient, as rapidly as possible.