European regulators approve new Alzheimer’s drug after rejecting it

European regulators initially said in July that the drug’s benefits did not outweigh its risks.

European regulators have recommended granting marketing authorisation for the Alzheimer’s drug lecanemab after an initial negative opinion earlier this year.
Lecanemab, marketed as Leqembi, is given as a drip every two weeks.
It’s a type of protein that attaches to amyloid beta, a substance that forms sticky plaques in Alzheimer’s patients’ brains.
Alzheimer’s disease is an incurable neurodegenerative disease that is the most common form of dementia. It impacts an estimated 7.8 million people in the European Union.
Leqembi was shown in a trial to slow cognitive decline related to the disease.
EU regulators said in July that the treatment’s potential benefits in slowing cognitive decline did not outweigh the risk of serious side effects, including “swelling and potential bleedings in the brain of patients” who received it.
The drug is only authorised for people with one or no copies of a specific gene called ApoE4. Having this gene is a known risk factor for Alzheimer’s disease.
But regulators said people missing the gene or having a single copy of it were less at risk of developing side effects than those with two copies of the gene.
“Leqembi will be available through a controlled access programme to ensure that the medicine is only used in the recommended patient population,” the EMA said, with patients monitored for serious side effects through brain scans.
US regulators approved Leqembi in 2023 and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) approved the product in August.
However, the drug is not available on the UK’s National Health Service (NHS) after it was determined to have too little benefit to justify the cost.