The European Medicines Agency has declined to approve a new Alzheimer’s disease treatment for use in the EU. Aducanumab does not appear to be effective in treating people with early-stage symptoms, according to the EMA.
Alzheimer’s organisations have expressed disappointment with the decision, claiming that thousands of patients will be left without treatment alternatives.
The medicine was controversially approved in the United States in June, marking the first new treatment in more than two decades. Despite the fact that it targets amyloid, a protein that produces abnormal clumps in the brains of people with Alzheimer’s disease, many scientists at the time thought there was little evidence from studies that it was beneficial.
Biogen, the drug’s manufacturer, has two weeks to request that the EMA’s decision be reconsidered. It’s unclear whether the company would file a second application for clearance with the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA).
The European Medicines Agency made its conclusion based on two major trials that evaluated the effects of a low dose and a high dose of the medicine with a dummy tablet in over 3,000 individuals with early-stage Alzheimer’s disease.
After 78 weeks of treatment, the patients with moderate cognitive impairment or mild dementia had their symptoms examined.
The EMA stated that “results from the main studies were mixed and did not suggest that aducanumab was helpful in treating adults with early-stage Alzheimer’s disease.”
The EMA determined that the drug’s benefits did not outweigh its dangers and recommended that marketing authorization be denied. Nearly 8 million individuals in the EU and around a million in the UK are projected to have dementia, with numbers expected to quadruple by 2050. The bulk of those cases is assumed to be caused by Alzheimer’s disease.
According to the Alzheimer’s Society, there are currently around 125 Alzheimer’s medications in clinical trials, and additional money is needed to expedite their availability.