BRUSSELS: The European Medicines Agency has said that its committee for assessing medicines recommended “not granting a marketing authorization” to Alzheimer’s drug lecanemab.

According to the announcement by the EMA, which is under the European Union, on Friday, the committee pointed out that the effect of lecanemab, developed jointly by Japan’s Eisai Co. and U.S. drugmaker Biogen Inc., in delaying cognitive decline “does not counterbalance” the risk of serious side events, such as bleeding in the brain.

“We are extremely disappointed” by the EMA committee’s negative opinion and “understand that this may also be disappointing for the wider Alzheimer’s disease community,” Eisai said in a statement, adding that the company will seek re-examination by the committee.

Eisai applied for sales approval of the drug to the EMA in January 2023.

Lecanemab was developed to treat patients in early stages of Alzheimer’s disease. Clinical trials confirmed that patients given lecanemab saw the progress in their symptoms slow by 27 percent compared with those who did not take the medicine.

The drug is already on sale in countries including Japan and the United States.

JIJI Press