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European Medicines Agency approves alemtuzumab (Lemtrada) for relapsing remitting MS

The European Medicines Agency yesterday approved alemtuzumab (Lemtrada) for relapsing remitting MS. Alemtuzumab is an intravenous infusion drug that showed good results in two Phase III clinical trials (read the MS Research Australia news article here).

Alemtuzumab is given by intravenous infusion for 5 days at baseline and then for 3 days after 12 months. It is a monoclonal antibody that targets and reduces B- and T-cells of the immune system. Alemtuzumab has previously been licenced as a treatment for B-cell chronic lymphocytic leukaemia.

Alemtuzumab is currently under review by the USA Federal Drug Administration (FDA) for MS and the sponsor of alemtuzumab, Sanofi subsidiary Genzyme, has announced that they expect a decision by the end of 2013.

In Australia, new medications require approval from the Therapeutic Goods Administration before they are available by private prescription. Evaluation by the Pharmaceutical Benefits Advisory Committee is then required for reimbursement on the Pharmaceutical Benefits Scheme. These processes can take in the region of 18 months to two years.

MS Research Australia welcomes the development of new treatment options for people with MS that have undergone rigorous clinical testing and this announcement in Europe is certainly encouraging for the future introduction of this new choice for Australians with MS.

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European Medicines Agency approves alemtuzumab (Lemtrada) for relapsing remitting MS