The EU takes the first step towards approving a drug that could stop the progression of Alzheimer’s disease

The European Medicines Agency (EMA) has given the Commission approval for the marketing and use of Lekembi, a medicine that has been shown to be able to delay the progression of Alzheimer’s disease in people identified at an early stage. This is the first compound capable of targeting the disease’s mechanisms and slowing its progression under certain circumstances, so its upcoming availability in Europe will be a major milestone in the research and treatment of Alzheimer’s disease on the old continent. Its use was approved in the US in January last year and is also permitted in countries such as Japan, China and the UK.

Clinical studies have proven that the progression of the disease and the subsequent process of dementia is slowed by 27% in those patients with mild cognitive impairment who were prescribed the drug.

In 10%-20% of cases

Such successful results in individual patients and the presence of side effects mean that the EMA has partially approved the use of lekanemab (name of the substance; Lekembi is a trade name). Its possible use is limited to people with “one or no copy of ApoE4,” a genetic characteristic that increases the risk of getting the disease. Given that this population is more likely to suffer from the disease, they are also less likely to suffer from the risky side effects found, such as bleeding or inflammation in the brain.

Experts estimate that these limitations (genetic and early diagnosis) will mean that this drug may be prescribed in 10% to 20% of recent or future diagnoses. As far as is currently known, Lekembi will not be used in people with advanced Alzheimer’s disease.

The EMA’s decision, which in July issued a negative report on the general purpose of treatment for patients diagnosed at an early stage, satisfied health care providers, patients, researchers and Alzheimer’s disease associations.

In Gipuzkoa, the scientific director of the CITA Alzheimer’s Foundation, Pablo Martínez-Lage, does not hesitate to call the EMA’s decision “fantastic news.” This neurologist explains that using Lekembi “changes the progression of the disease at a stage when people are still living a normal life,” meaning they “gain time to live autonomously.”

Regarding the drug’s risks, he has no hesitation in supporting its use on a risk-benefit basis. “Given the achievement of a 27% slowdown in the rate of disease progression, the risk of side effects is estimated to be 15–20% of treated patients,” he explains. He adds that “it is also a manageable risk, since periodic control resonances will have to be carried out, which will allow treatment to be stopped if necessary.”

Indeed, the EMA states that patients “should undergo an MRI before starting treatment and before the 5th, 7th and 14th doses,” with the possibility of additional ones if symptoms are detected.

“Adapt the system”

In the same vein, neurologist Gurutz Linazasoro evaluates this “good news” as a “milestone” because “we are beginning to understand that Alzheimer’s disease is preventable.” This researcher explains that the drug “clears deposits of amyloid beta,” an abnormal protein that “plays an important role in neuronal death.”

Linazasoro warns that “the health care system will have to adapt to this new treatment” because it requires hour-long intravenous infusions every two weeks and more MRIs.