A groundbreaking medication designed to delay the onset of Alzheimer’s has received approval for use within the EU. The drug, which is given via an intravenous drip every two weeks, has been proven in clinical trials to decrease amyloid plaques. It has also already been given the green light for use in the UK.
Alzheimer’s disease is an irreversible and progressive brain disorder that impacts memory, thinking and behaviour. The NHS explains “Alzheimer’s disease is thought to be caused by the abnormal build-up of proteins in and around brain cells. One of the proteins involved is called amyloid, deposits of which form plaques around brain cells. The other protein is called tau, deposits of which form tangles within brain cells.”
Just this week on Thursday, the EMA, also known as the European Medicines Agency, approved the long-awaited treatment designed to reduce cognitive decline in Alzheimer’s sufferers, after initially blocking it in July, reports RTBF Actus. Only accessible to some, the treatment, marketed under the name Leqembi, is now recommended by the EMA 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 added.
Initially rejecting it, the use of Leqembi was declined as the EMA believed at the time of refusal the effect of the treatment did not outweigh the risk of serious side effects, including potential bleeding in the brain. Despite this, this week the treatment was approved for patients with a lower risk of potential brain haemorrhage stating people with “only one or no copy of the ApoE4 gene” could use it. This is a “type of gene known to be a major risk factor for Alzheimer’s disease”.
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. Even those who have one copy have an increased risk.
Leqembi, which is developed by the Japanese pharmaceutical company Eisai and the American manufacturer Biogen, has already been approved for use in the United States almost a year ago in January 2023. This is for patients who have not reached an advanced stage of the disease. It is also marketed in Japan and China, and in the UK with the latter 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 happened just months ago on August 22 2024. 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 can occur naturally in all patients with Alzheimer’s disease, but it is exacerbated by taking medicines such as Leqembi, i.e., antibodies targeting amyloid beta. In the re-examination requested by the company, the CHMP considered subgroup analyses which excluded data from patients who carried 2 copies of the ApoE4 gene and were therefore 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. As with all medical products, we will keep its safety under close review, and with a controlled post-authorisation safety study to be undertaken, we will ensure that the benefit/ risk of lecanemab in clinical use is closely followed up.”
As reported by eldiario, the 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,” as she told the Science Media Center (SMC).
Rovira adds that “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, also sees the partial approval as positive: “Although not a cure, lecanemab is an important step forward,” she also told SMC. “This progress, however modest, is a major advance in the way Alzheimer’s disease is treated”. However, the drug will be “made available through a controlled programme to ensure that the medicine is used only in the right patients,” the EMA said in announcing the re-evaluation, it’s further reported.