EMA: No Recommendation for Marketing Authorization for Alzheimer's drug "Aducanumab”

The Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) has recommended against the marketing authorization of the novel Alzheimer’s drug “Aducanumab” (brand name: “Aduhelm”).

EMA Press Release (December 17, 2021)

Biogen, the company that applied for authorization, may now ask for re-examination within 15 days. The legally binding decision on marketing authorization ultimately lies with the European Commission. 

Background on Aducanumab / Aduhelm

The drug is jointly produced by the companies Biogen and Eisai. In the U.S., it was approved in June 2021 on the condition that the manufacturers demonstrate a clinical benefit at a later date. This decision by the U.S. Food and Drug Administration (FDA) is the subject of controversy. Aducanumab targets deposits of the protein “amyloid” (so-called plaques) that occur in the brain in Alzheimer’s disease.

The drug consists of the genetically engineered antibody “Aducanumab” which is marketed under the brand name “Aduhelm”. The joint manufacturers are the companies Biogen and Eisai. The antibody binds to so-called amyloid-beta proteins. In individuals with Alzheimer’s disease, these proteins accumulate in the brain and form aggregates - called “plaques” - in the vicinity of neurons. Due to this phenomenon and other evidence, amyloid-beta proteins are considered to be important protagonists in the disease process.

Clinical trials in which Aducanumab was administered by infusion showed that this treatment significantly reduced the amount of plaques in the brain. In one study, there was also evidence that the treatment could slow mental decline to some extent in people with early Alzheimer’s disease, but a second study could not demonstrate this effect. In view of these contradictory findings, there is controversy as to whether patients can benefit from treatment with Aducanumab.

Conventional therapies only alleviate symptoms of Alzheimer's disease. In contrast, Aducanumab is considered the first drug to target mechanisms and potential causes of the disease.

In the U.S., Aducanumab is currently approved for the treatment of people with mild cognitive impairment or mild form of Alzheimer’s dementia. 

In December 2021, Biogen and Eisai announced the start of a clinical trial in 2022 to provide FDA-required evidence of clinical effectiveness.
 

December 2021