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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