Michel Vounatsos, Biogen CEO (Credit: World Economic Forum/Valeriano Di Domenico)

Eu­ro­pean drug reg­u­la­tor votes down Bio­gen's con­tro­ver­sial Alzheimer's drug

Fol­low­ing an oral ex­pla­na­tion held at the No­vem­ber meet­ing of the EMA’s hu­man med­i­cines com­mit­tee, Bio­gen re­ceived “a neg­a­tive trend vote” on its mar­ket­ing ap­pli­ca­tion for its con­tro­ver­sial Alzheimer’s drug ad­u­canum­ab, the com­pa­ny said Wednes­day morn­ing.

The set­back is just the lat­est in a string of neg­a­tives — from an ane­mic launch to re­jec­tion of cov­er­age from the VA — since the sur­pris­ing June ap­proval of the drug by the FDA that led to mul­ti­ple res­ig­na­tions from an ad­vi­so­ry com­mit­tee that unan­i­mous­ly re­ject­ed it.

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