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Breaking News, Trials & Filings

Genzyme MS Treatment Approved in Australia

Follows approvals in Canada, EU

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Genzyme, a Sanofi company, has received approval from the Australian Therapeutic Goods Administration (TGA) for Lemtrada (alemtuzumab) for the treatment of relapsing forms of multiple sclerosis (RRMS) for patients with active disease defined by clinical or imaging features to slow the accumulation of physical disability and reduce the frequency of clinical relapses.

Lemtrada 12 mg has a novel dosing and administration schedule of two annual treatment courses. The first treatment course of Lemtrada is administered via intravenous infusion on five consecutive days, and the second course is administered on three consecutive days, 12 months later.

The approval was supported by a clinical development program that involved nearly 1,500 patients and 5,400 patient-years of follow-up. Lemtrada’s clinical program included two pivotal randomized Phase III studies comparing treatment with Lemtrada to high-dose subcutaneous Rebif (interferon beta-1a) in patients with RRMS who had active disease and were either new to treatment or who had relapsed while on prior therapy, as well as an ongoing extension study.

This approval follows the recent approval of Lemtrada in Canada and the EU. Marketing applications for Lemtrada are also under review in other countries.

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