The European Medicines Agency is preparing to approve lecanemab, a controversial Alzheimer’s disease drug.

Lecanemab is perhaps the best pharmacological agent we have in the fight against Alzheimer’s disease. It is also a source of controversy, the latest of which involves the European Medicines Agency (EMA) changing course on the treatment.

Changing criteria. The EMA Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for Lekembi, the name under which lekanemab will be marketed. The decision represents a change of course since the agency decided over the summer not to authorize the drug in Europe.

The committee’s decision is not strictly binding, but the agency is expected to follow its recommendations and approve the drug. Of course, lecanemab will be presented with some restrictions to reduce the risk of side effects.

What is lecanemab? Lecanemab is a drug indicated for the treatment of mild cognitive impairment caused by Alzheimer’s disease in adults; as well as treating the disease itself at an early stage, explains the Spanish Agency for Medicines and Health Products (AEMPS).

Clinical trials of the drug have shown it to be effective in slowing the onset of symptoms associated with Alzheimer’s disease, with a delay of 27%, according to data from a clinical study of nearly 1,800 participants.

Why did you retire? Clinical trials have shown the drug’s effectiveness, but also important risks associated with its use. Some patients have experienced adverse reactions to the drug, including swelling and possible bleeding.

The problem is related to the emergence of amyloid-associated imaging abnormalities (ARIA). These problems can occur in any patient with Alzheimer’s disease, but they are exacerbated by the use of drugs such as lecanemab, which are based on antibodies that target amyloid beta. There is also a known connection between the development of ABCA and the presence of two or more copies of the ApoE4 gene, a form of the apolipoprotein E protein gene.

Side effects are one of the factors limiting the use of this drug by patients with Alzheimer’s disease. The high price, the fact that it targets early stages of the disease, and its complex application are also important factors hindering its widespread use.

What has changed? According to AEMPS, in July this year the CHMP issued a “negative opinion” regarding the authorization of the drug for all patients with early Alzheimer’s disease. After the companies appealed, the committee changed its criteria, establishing measures such as limiting possible users of the treatment.

According to the new recommendation, the drug can only be prescribed to people who have one or no copy of ApoE4. This is one of the key changes in the decision: if the first “expertise” of the drug was about its use in all patients in the early stages, now the population of potential users is reduced to those who are least likely to be used. to the development of complications.

Additionally, additional preventive measures are established. For example, as AEMPS states, “patients should undergo an MRI to monitor ABCA before starting treatment and before the fifth, seventh, and fourteenth doses of Lekembi,” without excluding additional monitoring in cases where this is considered necessary.

From the Union to the countries. Once the resolution is adopted, it will be the European Commission’s turn to grant treatment authorization to the European Union. After this, the agencies of each state will have to continue the process of delivering the drug to the pharmacies of each of the member states. This follows in the footsteps of countries such as the US, China and Japan, where the drug has already been approved.

In Hatak | Technologies and devices that allow us to move to the next level in the fight against Alzheimer’s disease

Image | Anna Shvets