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Alzheimer’s Drug Aducanumab Faces Uphill Battle To Be Approved in EU

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The amyloid-beta antibody aducanumab was issued a “negative trend vote” by European regulators, announced its developer Biogen in a statement on November 17.

Aducanumab’s rollercoaster development reached an exhilarating peak earlier this year when it was approved by the US Food and Drug Administration (FDA) for the treatment of Alzheimer’s disease. It is the first drug to be licensed for the condition in nearly two decades, and the first to be based on the contentious “amyloid hypothesis” of the disease. That approval was contentious and came with caveats – not only did the FDA’s decision go against the advice of its independent advisory board, but it also required Biogen to conduct a post-approval randomized clinical trial to produce more data on the drug’s efficacy.     

While many patient groups, such as the Alzheimer’s Association, released statements suggesting they were delighted with the drug’s progress, negative reaction from some experts began a precipitous dip for the drug. There are more twists and turns ahead, suggests a statement from Biogen, which reflects on the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA)'s reaction to the drug. The CHMP must give its approval before aducanumab can be made available to Europe-based patients.

What is adunacumab?

The brains of AD patients are often found to be riddled by amyloid plaques that disrupt healthy neuronal function and cause toxicity, ultimately leading to cognitive decline. Aducanumab is a monoclonal antibody (mAb) designed to bind to aggregated forms of β-amyloid to clear it. The drug was originally developed by Neurimmune via a reverse translational medicine approach, in which the antibody was extracted from older individuals that have not developed AD.

While not yet an outright “no” to aducanumab, the “negative trend vote” that Biogen says it received certainly does not bode well for the formal opinion that CMHP is scheduled to adopt at its December meeting (December 13-16).

The committee was voting whether to approve aducanumab under its trade name, ADUHELM, an injection of a 100 mg/mL solution of the monoclonal antibody, which targets the amyloid-beta protein thought to play a central role in the disease’s pathology.

Dr. Priya Singhal, head of global safety and regulatory sciences and interim head of research and development at Biogen, commented in a press release, “While we are disappointed with the trend vote, we strongly believe in the strength of our data and that aducanumab has the potential to make a positive and meaningful difference for people and families affected by Alzheimer’s disease.”

In a pair of earlier clinical trials, aducanumab showed an impressive clearance of the amyloid protein, but only modest improvements in cognition that critics said were based on flimsy data.

David Thomas, head of policy at Alzheimer’s Research UK, commented on the announcement in a release by the UK Science Media Centre, “We urgently need new treatments for Alzheimer’s disease, but it’s vital that regulators judge that any new treatment is safe and effective. Results of aducanumab’s phase III trials, EMERGE and ENGAGE, have sparked much debate among the research community about how to judge the effectiveness of any new Alzheimer’s treatment."

“The FDA’s approval of aducanumab in the US was based on the drug’s ability to clear the hallmark Alzheimer’s protein amyloid from the brain. As part of this approval the regulator now requires further trials to be carried out to ensure that aducanumab brings long-term improvement to people’s memory, thinking and day-to-day lives.”

This cautious tone, which was echoed in an SMC statement from Dr Richard Oakley, associate director at the dementia charity Alzheimer’s Society, contrasted with a scathing response from Robert Howard, a professor of old age psychiatry at University College London who has previously been critical of Biogen’s trials for the drug. Howard said, This is absolutely the decision that we should have expected from the EMA's expert advisory panel and is consistent with the FDA's Advisory Committee who voted unanimously 12 months ago against approval of aducanumab because of a lack of demonstrable efficacy in the pivotal phase 3 trials ENGAGE and EMERGE."

He added, “The FDA's Accelerated Approval of aducanumab, solely on the grounds that it was reasonable to expect that reduction in amyloid would lead to improvement in the course of Alzheimer's disease, despite all the evidence indicating no meaningful correlation between amyloid reduction and symptom improvement, has been highly controversial and has called into question the impartiality of the FDA and its Staff," Before concluding, "“I would anticipate that [the] EMA, when they meet in December, will not grant a license to aducanumab. Aducanumab is a treatment without convincing efficacy, with serious associated adverse effects and a high financial cost. On the basis of the available evidence and in the best interests of people with Alzheimer's disease, their families and those who care for them, EMA and MHRA should not approve a license for aducanumab.”