The European Medicines Agency (EMA) has approved a treatment designed to reduce cognitive decline in early-stage Alzheimer’s patients. It is known as Leqembi which has received marketing authorization after initially being refused.
Alzheimer’s patients, an extra chance at a normal life. Source: archive
In the summer of this year, the European Medicines Agency ruled against the marketing of the Leqembi treatment in the EU, the main reason being the high risk of serious and very serious side effects such as possible bleeding in the brain. Recently, however, EMA experts returned to the decision. “After revising its initial opinion, the EMA’s Committee for Medicinal Products for Human Use has recommended that Leqembi be given marketing authorization for the treatment of mild cognitive impairment (speech and thought disorders) or mild dementia caused by early Alzheimer’s disease and only for certain groups of patients. One review concluded that the benefits outweigh the risks in a limited patient population,” EMA representatives explained.
What is Leqembi, the miracle treatment against Alzheimer’s
The Leqembi treatment was developed by the Japanese pharmaceutical laboratory Eisai together with the American manufacturer Biogen. It was authorized in January 2023 in the United States for patients who were at the onset of the disease, but it is also marketed in Japan and China. And the UK medicines regulator approved the treatment in August.
But the drug only targets patients with a single copy of the ApoE4 gene (or no children). This gene is known as one of the major risk factors for the development of the disease.
In terms of effectiveness, after 18 months of treatment with Leqembi, patients had a smaller increase in the CDR-SB score, a dementia rating scale, compared to patients in the placebo group. Which indicates slower cognitive decline.
How to take Leqembi
Alzheimer’s disease occurs due to the accumulation of amyloid plaques around neurons, and this leads to irreversible brain damage. The patient initially loses his memory, but in the advanced stages of the disease, affected people lose the ability to carry out daily tasks and carry on simple conversations. The active substance in Leqembi, lecanemab, is a monoclonal antibody that targets beta-amyloid, reducing plaque formation. Leqembi treatment is administered intravenously, once every two weeks
The decision announced by the EMA represents an intermediate step towards patient access to the medicine. Now, it will be sent to the European Commission in order to adopt a marketing authorization at the level of the European Union. Decisions on pricing and reimbursement will then be made at the level of each EU Member State.
