Lekembi is approved for the treatment of Alzheimer’s disease with restrictions.

• The decision limits Lakembi’s use to treat Alzheimer’s disease to patients who have one copy or no copy of ApoE4, a certain form of the apolipoprotein E protein gene.
• This population is less likely to experience amyloid-associated imaging abnormalities (ARIA), a known serious adverse reaction including edema (edema) and possible brain hemorrhages.
• The Committee for Medicinal Products for Human Use concluded that in the limited population assessed in this new review, the benefits of Lekembi in slowing the progression of disease symptoms outweigh the risks.
• Lekembi will be available through a controlled access program to ensure its use only among a recommended group of patients.

The European Medicines Agency, having re-evaluated its original opinion, has recommended marketing authorization for Lekembi (lekanemab), a medicinal product intended for treatment of adults with mild cognitive impairment due to Alzheimer’s disease and early Alzheimer’s diseasewith limited indication. The decision taken by the Committee for Medicinal Products for Human Use, of which the Spanish Agency for Medicines and Health Products (AEMPS) is part, limits the use of this medicine to patients who have one or no copy of ApoE4, i.e. form of the apolipoprotein E protein gene.

This population is less likely to experience amyloid-associated imaging disorder (ARIA), a known serious adverse reaction including edema (swelling) and possible brain hemorrhages, than people with two copies of ApoE4.

The Committee for Medicinal Products for Human Use concluded that in the limited population assessed in this new review, the benefits of Lekembi in slowing the progression of disease symptoms outweigh the risks. In July 2024, the committee issued a negative opinion on the use of this drug among all patients with early-stage Alzheimer’s disease.

Lekembi will be available via a controlled access program to ensure that the drug is used only in the recommended patient population..

ARIA manifests itself in two ways: ARIA-E (edema), which involves fluid accumulation in the brain, and ARIA-H (hemorrhage), which involves small bleeds in the brain. This can occur naturally in all Alzheimer’s patients, but is exacerbated by medications such as Lekembi, which are antibodies that target amyloid beta. In a new evaluation requested by the pharmaceutical laboratory, the Committee for Drugs for Human Use considered a subgroup analysis that excluded data from patients who carried 2 copies of the ApoE4 gene and were therefore at greater risk for ABC.

The results of these analyzes showed that among patients treated with Lekembi, 8.9% of patients with one or no copy of ApoE4 had ARIA-E compared with 12.6% of all patients; Similarly, 12.9% of patients in the limited population experienced ABCA-H compared with 17.3% in the broader population. Among patients receiving placebo, these figures were 1.3% and 6.8% for ARIA-E and ARIA-H, respectively, in the limited population.

Additional Security Measures on the use of Lekembi in patients with Alzheimer’s disease

The Committee for Medicinal Products for Human Use concluded that the benefits of Lekembi outweigh the risks in patients with mild cognitive impairment or mild dementia due to Alzheimer’s disease, with or without one copy of ApoE4, provided that measures are taken to reduce the risk minimizing risk. severe and symptomatic ARVI and monitor its long-term consequences.

Patients will need to undergo an MRI to monitor ABCA before starting treatment and before taking their fifth, seventh, and fourteenth doses of Lekembi. Additional MRIs may be needed at any time during treatment if patients develop cold symptoms (such as headache, confusion, vision changes, dizziness, nausea, and trouble walking).

To increase awareness of BCA and ensure early detection and treatment, the pharmaceutical company will provide a guide and checklist for healthcare professionals, as well as training programs on BCA, and an alert card for patients. In addition, you should conduct a post-marketing safety study to better characterize ARIA-E and ARIA-H and evaluate the effectiveness of risk minimization measures. The laboratory will also conduct an EU-wide registry study of patients receiving Lekembi, which can be used to assess the incidence of adverse reactions, including ABCA, and determine their severity. This study will also collect information on patients’ progression to the next stages of Alzheimer’s disease and the potential long-term consequences of ARIA.

As with other assessments, the Committee for Medicinal Products for Human Use took into account the views of patients, caregivers, health care professionals and organizations about the unmet needs of patients with Alzheimer’s disease, as well as data on cognitive decline and risks. .

The positive opinion from the Committee for Medicinal Products for Human Use is an interim step before Lekembi reaches patients. The European Commission (EC) will now be responsible for issuing this marketing authorization so that it can be distributed in all EU Member States, as is the case for the rest of the medicines authorized under the centralized procedure.

Fountain: Spanish Agency for Medicines and Health Products.

If you liked this news and want to learn more about genetics in medicine, you might be interested in our trainings, such as “Master of Precision Medicine and Clinical Genetics“, or “University expert in neurogenetics“.