European Medicines Agency refuses to license Aduhelm, a drug for Alzheimer’s

The European Medicines Agency (EMA) refused to endorse a license for the use in the European market of Aduhelm, a drug intended to directly treat Alzheimer’s, due to “contradictions” in the results of the main studies and the lack of data on its safety.

The experts considered that “the link has not been established” between the reduction of the substance called beta amyloid, which produces toxicity in the brain, and the clinical improvement in patients with Alzheimer’s that this therapy, developed by Biogen, promises.

Furthermore, they allege that the results of the main studies were “conflicting” and, overall, Aduhelm was not shown to be “effective” in treating adults with early stage disease.

Studies did not show that the drug was safe enough, as images from brain scans of some patients showed abnormalities that suggested swelling or bleeding, which could cause harm. Furthermore, it is not clear that the abnormalities can be adequately controlled and treated in clinical practice, ”says the EMA.

The agency’s opinion was that Aduhelm’s benefits do not outweigh its risks and it recommended that the European Commission deny the drug’s marketing authorization to treat this degenerative disease, which affects around 30 million people globally.

The drug costs around $ 56,000 (about 50,000 euros) per patient per year.

The uncertainty about the potential benefits of Aduhelm, which received conditional approval from the US Food and Drug Administration (FDA) on June 7, is considerable.

In fact, a month after its approval, the United States decided to restrict its use, after a wave of criticism from the scientific community, which has questioned the effectiveness of the new drug in patients with more severe symptoms. It will now only be given to people who have suffered mild cognitive impairment from the degenerative disease.

The active substance in Aduhelm, aducanumab, is a monoclonal antibody (a type of protein) that attaches to beta amyloid that forms plaques in the brains of people with the disease. By adhering to this substance, the drug is expected to help remove plaques and delay the worsening of Alzheimer’s, which the EMA does not consider proven.

To apply for a license in the European market, the company presented the results of two main studies of more than 3,000 early-stage Alzheimer’s patients that compared the effects of a low and high dose of Aduhelm with the effects of a placebo.

The studies looked at how patients’ symptoms changed after 78 weeks of treatment using a standard scoring system.