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.
“This withdrawal is based on interactions with the CHMP indicating that the data provided thus far would not be sufficient to support a positive opinion on the marketing authorization of Aduhelm(aducanumab),” Biogen Netherlands B.V. told the EMA in a letter dated April 20. The company previously said it would appeal the EMA decision.
The EMA also previously raised concerns about the safety of the drug, when it first recommended rejecting it back in December, noting:
The studies did not show that the medicine was sufficiently safe as images from brain scans of some patients showed abnormalities (amyloid-related imaging abnormalities) suggestive of swelling or bleeding in the brain, which could potentially cause harm. Furthermore, it is not clear that the abnormalities can be properly managed in clinical practice.
Meanwhile, the company’s data on how the drug affected cognition are “conflicted,” the EMA said. One of two identical studies failed; the other showed a small benefit in the high dose cohort. These studies “did not show overall that Aduhelm was effective at treating adults with early stage Alzheimer’s disease,” EMA said.
Layoffs at the company have piled up recently as it plans $500 million in cost-cutting measures.
Meanwhile, the FTC, SEC, FDA, HHS inspector general, and the US House committees on Oversight and Energy & Commerce are all conducting investigations into the approval and the close relations between the FDA and Biogen. The congressional investigation launched last July, as representatives sought from the company a variety of different internal and external documents and communications relating to assessments of Aduhelm’s safety, efficacy, and clinical benefit.
