A glimmer of hope for patients with mild Alzheimer's disease: the drug Leqembi has now been approved by the European Medicines Agency. In June it was rejected citing cerebral hemorrhage as a side effect.
The European Medicines Agency (EMA) has approved the Alzheimer's drug Leqembi for certain patient groups. It recommends that “Leqembi (lecanemab) be approved for the treatment of mild cognitive impairment or mild dementia due to Alzheimer's disease,” the EMA said. At the end of July, the agency refused to approve the drug, citing side effects, particularly cerebral hemorrhages.
The EMA has now restricted approval to patients who do not have an increased risk of cerebral hemorrhage due to genetic predisposition. For this segment of potential patients, “the benefits of Leqembi outweigh the risks,” the agency said.
In order to reduce the risks of serious side effects, access to Leqembi must be controlled so that it is only administered to suitable patients. In addition, the health of those affected must be checked with magnetic resonance imaging (MRI) before and during treatment.
In its previous rejection, the EMA had stated that Leqembi was “effective”, but that its positive effect “does not offset the risk of serious side effects”, particularly cerebral hemorrhages.
Drug is administered intravenously
In August, the British Medicines Regulatory Authority (MHRA) approved Leqembi with similar restrictions to those now imposed by the EMA. The drug was approved in the USA last year.
Leqembi, based on the new active ingredient lecanemab, is intended to help patients whose Alzheimer's disease has not yet progressed far. The drug is injected intravenously every two weeks and is directed against a protein called beta-amyloid, which causes deposits in the brains of Alzheimer's sufferers. Although this cannot cure those affected, it can apparently slow down the progression of dementia.
Alzheimer's researchers and charities also point out that lecanemab is the first drug recognized to fight the disease in its early stages rather than treating the symptoms.
Alzheimer's disease is the most common form of dementia. More than one in nine people over the age of 65 get the disease, which robs those affected of their memories and worsens over time.
AFP/sara
