Tuesday July 25th 2017

[Editorial] Alemtuzumab and the value of neurological research

The announcement by the US Food and Drug Administration (FDA) on Dec 27, 2013, to reject an application for the use of alemtuzumab in relapsing-remitting multiple sclerosis (MS) has caused a stir within the neurological community. Investigators involved in two large phase 3 trials that tested its safety and efficacy expressed discontent; patients’ organisations protested the decision; the drug makers announced their intention to appeal this initial ruling (which is subject to further regulatory review); and even an opinion piece in the Wall Street Journal called for FDA reform, given such “vivid example of the serious problems besetting US drug regulation”. (Source: Lancet Neurology)

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[Editorial] Alemtuzumab and the value of neurological research

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