Scientists have been searching for a cure for Alzheimer’s disease, which causes dementia, for many years.
The European Union has refused to approve a new drug for Alzheimer’s disease. We are talking about aducanumab – the first new drug for Alzheimer’s in 20 years, which was approved in the US this summer.
The drug, which in the U.S. was said to have little evidence of benefit, is designed to prevent amyloidosis – a disorder of protein metabolism that leads to the buildup of abnormal proteins in people’s brains, impairing their ability to think.
The European Medicines Agency (EMA), which reviewed the possibility of approving aducanumab for use in the European Union, concluded that aducanumab was not effective in treating adults with early-stage symptoms. The agency based its decision on the results of two long-term studies involving more than three thousand people with early-stage Alzheimer’s disease. Some people took aducanumab for 20 months, while others took a placebo. At the end of this period, scientists compared their condition with how it was at the beginning.
“The results were inconsistent and overall did not show that aducanumab is effective in treating adults with early-stage Alzheimer’s disease. In addition, brain scans in some patients showed signs of edema or bleeding, which could potentially harm the patient. The results did not show that the drug is sufficiently safe,” the EMA said. The agency found that the drug’s benefits did not outweigh its risks and recommended denial of marketing approval.
Charities that help people with Alzheimer’s disease say they are disappointed by the decision because thousands of people have lost hope that the drug could help them, at least potentially. There are currently about 8 million people with dementia in the European Union and about one million in the United Kingdom. This number is expected to double by 2050. Most cases of dementia are caused by Alzheimer’s disease.
Biogen, the manufacturer of the drug, may file a request for review of the EMA’s decision within the next two weeks.