'Life changing' Alzheimer's drug is approved for use to reduce cognitive decline
by Sophie Buchan, Maria Ortega, Barbara Hodgson · ChronicleLiveA ground-breaking drug designed to delay the onset of Alzheimer's Disease has been approved for use within the EU, it is reported.
The medication has been proven in clinical trials to be decrease amyloid, a protein which can create deposits around brain cells. The NHS explains that an abnormal of proteins - one being amyloid and another called tau - can form plaques around brain cells and is thought to cause Alzheimer's, a progressive brain disorder that impacts memory, thinking and behaviour.
As The Express reports, the new drug has been shown to decrease amyloid plaques. And it has already received the green light for use in the UK, with approval granted in August.
On Thursday, the EMA (European Medicines Agency) approved the long-awaited treatment after initially blocking it in July, reports RTBF Actus. Now, marketed under the name Leqembi, it is recommended for patients who have not reached an advanced stage of the disease.
The European regulator explained. "A review has concluded that the benefits outweigh the risks in a restricted patient population." It had initially thought the effect of the treatment did not outweigh the risk of serious side effects, including potential bleeding in the brain.
The treatment is approved only for some patients - those with a lower risk of potential brain haemorrhage and who have only one or no copy of a type of gene, ApoE4, known to be a major risk factor for Alzheimer's disease, it said. The UK gov.uk website, states around 15% of those diagnosed with Alzheimer’s have two copies of this gene, known as homozygous patients, and are at increased risk of developing Alzheimer’s disease. Those with one copy are at increased risk too.
Leqembi, which is developed by the Japanese pharmaceutical company Eisai and the American manufacturer Biogen, has been approved for use in the US since January 2023. It is also marketed in Japan and China - and in the UK where it is under a different name.
Is the Alzheimer's drug available in the UK?
Yes, although it's called something different. GOV.UK states that the Medicines and Healthcare products Regulatory Agency (MHRA) "approved a product licence for the medicine lecanemab (Leqembi) for use in the early stages of Alzheimer’s disease, following a thorough review of the benefits and risks." This just happened on August 22 this year.
Lecanemab may come with side effects with the most most common being infusion-related reactions such as a fever and flu-like symptoms, headaches and ARIA, the government added.
The European Medicines Agency (EMA) states: "ARIA manifests in two forms: ARIA-E (oedema) involving the accumulation of fluid in the brain and ARIA-H (haemorrhage) involving small bleeds in the brain." It says it can occur naturally in all patients with Alzheimer’s disease, but it is exacerbated by taking medicines such as Leqembi, which have antibodies targeting amyloid beta.
In the re-examination requested by the company, analyses excluded data from patients with two copies of the ApoE4 gene making them at highest risk of ARIA.
Julian Beach, MHRA Interim Executive Director, Healthcare Quality and Access, said: "Licensing medicines which meet acceptable standards of safety, quality and efficacy is a key priority for us. We’re assured that, together with the conditions of the licence approval, the appropriate regulatory standards for this medicine have been met." She added safety, as with all medical products, will be kept under close review
As reported by eldiario, neurologist and clinical director of Ace Alzheimer Center in Barcelona, Mercè Rovira, believes that "it is the news we were waiting for with a certain caution, because the EMA is a very conservative entity that evaluates very much the risk situation of patients to be able to accept the treatment".
Rovira added: "Europe needed this news. It needed to know that we had the possibility to treat patients, we needed to know that all the research in this field would continue."
Alzheimer's Research UK's chief executive, Hilary Evans-Newton, said: "Although not a cure, lecanemab is an important step forward. This progress, however modest, is a major advance in the way Alzheimer's disease is treated". The drug will be made available through a controlled programme and used only in the right patients, said the EMA.
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