2021-12-20| Trials & Approvals

EMA Rejects Marketing Authorization Application of Aduhelm

by Arvind C. Shekhar
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The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has denied approval for the Marketing Authorization Application (MAA) of Biogen and Eisai’s Alzheimer’s disease therapy Aduhelm, saying it was unconvinced by the data submitted for the drug. As of October 2017, Biogen and Eisai Co., Ltd. are collaborating on the global co-development and co-promotion of Aduhelm.

Biogen Netherlands B.V., the company that applied for authorization, can seek a re-examination of the opinion by the CHMP within the next 15 days and has already said it will do so seeking clarification on the grounds for refusal of the marketing application.

Aduhelm and its Proposed Mode of Action 


Aduhelm was intended for the treatment of the early stages of Alzheimer’s disease known as mild cognitive impairment (MCI) and mild Alzheimer’s disease dementia. 

Aducanumab, the active compound in Aduhelm, is a monoclonal antibody that attaches to amyloid beta which forms plaques in the brains of people with Alzheimer’s disease. The accumulation of amyloid beta plaques in the brain is a defining pathophysiological feature of Alzheimer’s disease. Aducanumab was expected to help clear the plaques away and delay the worsening of the disease. 

The company presented results of two main studies of over 3,000 patients with early stage Alzheimer’s disease comparing the effects of a low- and high-dose of Aduhelm with the effects of placebo (a dummy treatment). The studies looked at how the patients’ symptoms changed after 78 weeks  of treatment using a standard scoring system known as CDR-SB.

Conflicting Results and Side Effects 


The European Medicines Agency noted that, although Aduhelm reduces amyloid beta in the brain, the link between this effect and clinical improvement had not been established. Results from the main studies were conflicting and did not show overall that Aduhelm was effective at treating adults with early stage Alzheimer’s disease.

In addition, the studies show that Aduhelm was not sufficiently safe and can cause serious side effects including Amyloid Related Imaging Abnormalities (ARIA), a side effect where some people may have symptoms such as headache, confusion, dizziness, vision changes and nausea. As images from brain scans of some patients showed abnormalities suggestive of swelling or bleeding, which could potentially cause harm. “It is not clear that the abnormalities can be properly monitored and managed in clinical practice” said EMA in a question and answer document published alongside the CHMP decision.

Therefore, the Agency’s opinion was that the benefits of Aduhelm did not outweigh its risks and it recommended refusing marketing authorisation.

Reactions to the Decision


The decision of the EMA has been welcomed by many researchers and clinicians including Prof Robert Howard, Professor of Old Age Psychiatry, UCL Division of Psychiatry, who 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. He also added that “Aducanumab is a treatment without convincing efficacy, with serious associated adverse effects and a high financial cost”.

On the contrary, Priya Singhal, Biogen’s interim head of R&D asserted “For Europeans impacted by Alzheimer’s disease, the lack of options to treat its early stages is felt every day”, she added “The longer we wait, the more people will progress toward more advanced dementia and we may miss the opportunity to potentially treat them,”

Patient organizations have also expressed disappointment on EMA’s decision stressing that there were still no therapies that can slow down cognitive decline in people with dementia. 

David Thomas, Head of Policy at Alzheimer’s Research UK, called for “continuing work at pace to ensure researchers are developing a broad pipeline of potential new treatments for diseases like Alzheimer’s, and that health systems like the NHS will be ready to deliver them in the years ahead.”

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