The EMA does not recommend using Lekembi to slow the symptoms of Alzheimer’s disease.

The European Medicines Agency (EMA) yesterday ruled against the approval in the European Union of the drug Lekambi, designed to slow the symptoms of Alzheimer’s disease, given that the serious side effects associated with it do not offset the effects seen in slowing cognitive decline.

The EMA’s Committee for Medicinal Products for Human Use (CHMP) has concluded that the European Commission should not grant a marketing authorisation for lecanemab, trade name Leqembi, developed by Japanese pharmaceutical company Eisai and shown to be effective in slowing the effects of neurodegenerative diseases.

“The committee considered that the observed effect of Lekembi in slowing cognitive decline did not outweigh the risk of serious adverse events associated with the drug, in particular the frequent occurrence of amyloid-associated brain abnormalities (ABSAs), including swelling and possible bleeding, in the brain of patients receiving Lekembi,” he explained.

bleeding in the brain

A year ago, the U.S. Food and Drug Administration (FDA) approved the drug to slow the symptoms of Alzheimer’s disease, an irreversible neurodegenerative disease that destroys memory and the ability to perform tasks.

But the drug, which is given intravenously, has raised concerns over the possibility that it causes inflammation and bleeding in the brain – a condition that occurs in some Alzheimer’s patients and is known as ARIA.

The US regulator recommends against prescribing Lekembi to patients taking anticoagulant drugs because it increases the risk of brain bleeding, and stresses that it should be used in people with mild cognitive impairment and in the early stages of the disease.