In reversal, FDA approves Genzyme’s bid to sell MS drug in US

November 15, 2014 2:32 AM

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In reversal, FDA approves Genzyme’s bid to sell MS drug in US

Eleven months after rejecting a powerful multiple sclerosis drug considered key to the future of Cambridge biotech Genzyme, federal regulators Friday reversed themselves and approved sale of the medicine, called Lemtrada.

The Food and Drug Administration decision came after MS patients across the country called for more treatment options and Genzyme submitted a new analysis of clinical data to address FDA concerns about how the company had designed trials to test the drug’s safety and effectiveness.

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