FDA nixes Sanofi's Lemtrada; Genzyme plans appeal
This article was originally published in Scrip
Executive Summary
The FDA has refused to approve Sanofi/ Genzyme's monoclonal antibody product for multiple sclerosis, Lemtrada (alemtuzumab). In a complete response letter, the US agency says the company had not satisfactorily proven that the product's benefits outweigh its serious adverse effects. It will require further trials before the reconsidering Lemtrada's suitability for marketing in the US.
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