New drug against Alzheimer’s has good results, but safety concerns

An experimental drug called lecanemab has shown promise in the treatment of Alzheimer’s disease. According to the results of a recent Phase 3 trial conducted by the pharmaceutical companies Eisai and Biogen, the drug managed to moderately delay the effects of the disease, although it was associated with “side effects” for patients.

However, the experimental drug was one of the first to show measurable results in reducing the cognitive decline of the disease.
The strategy used by the two pharmaceutical companies was to use a monoclonal antibody, to reduce beta-amyloid protein levelsa known marker of disease in the brain.

As for adverse events, neurologist Marwan Sabbagh, one of the study’s authors, said: Washington post what happened? death of two patients from the group receiving the drug🇧🇷 The doctor said that although causation with lecanemab is difficult to establish, there is a low bleeding rate and an increased risk when associated with anticoagulants.

How was the Phase 3 study done with lecanemab?

Phase 3 study of Lecanemab was conducted from March 2019 to March 2021 at 235 sites in North America, Europe and Asia. mild dementia.

After 18 months of drug administration In half of the population that participated, the researchers measured a “clinical dementia score” (CDR-SB) of 3.2 at baseline. While this score increased by 1.66 in the placebo group, it increased less in the lecanemab group: 1.21 points.

Approval of the new drug will be sought in the USA by the end of March. In this sense, there is a Biological License Application for lecanemab, which has been accepted by the regulatory body FDA since July. Which should manifest by January 6, 2023.

ARTICLE 🇧🇷 New England Journal of Medicine – DOI: 10.1056/NEJMoa2212948.