Bio­gen pulls the plug on its Eu­ro­pean ap­pli­ca­tion for con­tro­ver­sial Alzheimer's drug

In an­oth­er blow to Bio­gen’s con­tro­ver­sial Alzheimer’s drug, the com­pa­ny has de­cid­ed to pull its ap­pli­ca­tion for the drug in Eu­rope af­ter reg­u­la­tors there re­ject­ed it late last year.

In mak­ing the de­ci­sion, the EMA ex­plained how, al­though Aduhelm (ad­u­canum­ab) re­duces amy­loid be­ta in the brain, the link be­tween this ef­fect and clin­i­cal im­prove­ment has not been es­tab­lished.

The FDA fa­mous­ly signed off on the drug last June un­der an ac­cel­er­at­ed ap­proval that al­lows for this con­fir­ma­to­ry clin­i­cal ben­e­fit to be es­tab­lished at a lat­er date, al­though the Cen­ters for Medicare and Med­ic­aid Ser­vices have since fi­nal­ized a de­ci­sion to not pay for use of the Aduhelm out­side of clin­i­cal tri­als, se­vere­ly re­strict­ing any im­me­di­ate sales of the drug.

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