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news.Alexion Pharmaceuticals, a biopharmaceutical company, has announced that the Australian Government's Therapeutic Goods Administration has approved the use of Soliris for the treatment of all patients in Australia with paroxysmal nocturnal hemoglobinuria.
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The marketing application submitted to the Australian regulatory authorities included safety and efficacy data from three multi-national clinical studies: Triumph, a placebo-controlled 26-week Phase III study involving 87 paroxysmal nocturnal hemoglobinuria (PNH) patients, Shepherd, an open-label 52-week Phase III trial involving 97 PNH patients, and E05-001, a long term extension study.
According to the company, Soliris is the first therapy approved in Australia for the treatment of PNH. A decision regarding funding of Soliris therapy for eligible patients is expected by the end of 2009.
Leonard Bell, CEO of Alexion, said: “This marketing approval reflects Australia’s recognition of the safety and efficacy of Soliris as a treatment for patients with PNH. Our Sydney-based organization will now work with the Australian federal healthcare authorities to obtain reimbursement for Soliris so that Australian patients with PNH who can benefit from Soliris will have access to it.”