What is it? When will it be available?
After more than 20 years of no news on the treatment of Alzheimer’s disease, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) published this Thursday a recommendation for the marketing of the drug Lekembi (lecanemab).
This drug is first to demonstrate clinical benefits according to the Spanish Society of Neurology (SEN), it affects more than 800,000 people in Spain, but as stated in the CHMP opinion, it is not without risks and its use should be limited and subject to a number of conditions.
What is Lekembi? Who is it recommended for?
Lekembi, made by pharmaceutical companies Eisai and Biogen, is indicated for the treatment of mild cognitive impairment or mild dementia in patients who have only one copy or no copy of ApoE4, a gene associated with the risk of developing Alzheimer’s disease. In studies, it has shown the ability to slow the progression of the disease by 27 percent.
The drug contains the active substance lecanemab and Administered by infusion (drip). into a vein once every two weeks. Lekembi’s active substance, lekanemab, is a monoclonal antibody (a type of protein) that attaches to a substance called beta-amyloid, which forms plaques in the brains of Alzheimer’s patients. By binding to beta-amyloid, Lekembi reduces amyloid plaques in the brain.
The drug will not be available to everyone; a controlled access program will be launched for it. ensure that the drug is used only in the recommended patient population..
What adverse effects could this cause?
As for the most common side effects, these include infusion reactions, ABCA-G, ABCA-E and headache.
In addition, the drug should not be used by people receiving anticoagulant treatment, as it may increase the risk of developing RVO-H and cerebral hemorrhages.
Neuroimaging changes associated with anti-amyloid treatment, known by the acronym ARIA, can occur naturally in all patients with Alzheimer’s disease, but are exacerbated by medications such as Lekembi. ABC may appear as swelling due to fluid accumulation in the brain (AVS-D) or as small cerebral hemorrhages (AVS-G).
When will it be available in Spain?
Thanks to the CHMP recommendation, European patients suffering from early stages of Alzheimer’s disease are closer to treatments they already have access to in other countries, e.g. USA, Japan, China, South Korea, Hong Kong and Israel.
Once the European Commission allows marketing at European Union level, it will be the pharmaceutical company that will apply for its registration in Spain – initially, as in other countries, this is not expected to take much time. for example, the financing of the drug in the Interministerial Commission on Prices of Medicines and Health Products (CIPM), which meets every month.
However, it is unknown exactly how long it will take for Alzheimer’s patients to start benefiting from Lekembi in Spain, but if the latest report “Indicators of Access to Innovative Treatments in Europe 2023” is taken into account. The European Federation of the Pharmaceutical Industry (EFPIA) notes that new drugs take an average of 661 days to reach patients.
Thus, according to available information, it can be assumed that Lekembi may appear on the Spanish pharmaceutical market in less than two years.
How much will it cost per patient?
Regarding the cost per patientthis will be determined by the CIPM, who will decide on its price and reimbursement taking into account the drug’s potential role and use in the National Health System (SNS).
If we take the price set in other countries as a guide, we find that in the USA the pharmaceutical laboratory Eisai set it at $26,500 per patient per year, which corresponds to approximately 25,076 euros.