The US Food and Drug Administration (FDA) has approved a new
Last year it was called "breakthrough" afterearly data from a phase 3 clinical trial showed the drug slowed cognitive decline. However, growing concerns about the drug's safety and actual effectiveness have led to disagreements among researchers. Some of them suggested banning the widespread use of the drug.
Lecanemab is a human IgG1 monoclonalan antibody with high affinity for soluble Aβ protofibrils. It is believed that it is the accumulation of soluble and insoluble amyloid-beta (Aβ) that may underlie or potentiate the pathological process of Alzheimer's disease.
Lecanemab is the second approved drugwhich works by reducing the accumulation of beta-amyloid in the brain through the work of monoclonal antibodies. This protein is believed to be the main pathological cause of the disease. The approval of the first drug in this class, Aduhelm (Aducanumab), in 2021 was heavily criticized. Questions over its effectiveness, safety and cost led several FDA consultants to resign, and one expert called it "probably the worst drug approval decision in recent U.S. history."
Pharmaceutical companies Eisai and Biogen,who were behind the development of Aducanumab are again working with monoclonal antibodies to use them against Alzheimer's disease. This is how the drug Leqembi was born. Recently published data from a phase 3 clinical trial showed that patients treated with the drug for 18 months had a 27% lower rate of cognitive decline than patients in the placebo group.
Since the end of 2022, pharmaceutical companiespublished phase three data, neuroscientists questioned the “true relevance of the cognitive benefits.” 12 scientists wrote an open letter and openly opposed the approval of Lekanemab. They stated that "the clinical benefits of the drug remain unclear."
“According to the analysis of available data, the effectivenessLecanemab is below levels considered clinically significant, the article says. — There are potential biases in the cohort due to inclusion bias, disclosure bias, and attrition, among other issues that may affect the validity of the data. Significant side effects and subgroup heterogeneity are clearly present. Thus, the translation of clinical trial data into real world effects is very uncertain.”
In addition, there were reports of severalcases of death of patients who took part in the extended third phase. Recently, information appeared in the media about three deaths caused by cerebral edema and microhemorrhages.
Independent neuroscientists whose newsScience asked to review patient records and concluded that death was likely caused by antibody treatment. But the pharmaceutical company Eisai said that the deaths of the test subjects were not related to Lecanemab, and all information about the patients “was disclosed to the FDA before the drug was approved.”
Read more:
See the most powerful volcanic eruption on Jupiter's moon
A new kind of quantum entanglement has been discovered: photons "remember" the structure of atoms
The metallicity of the Sun turned out to be higher than it was thought: what astrophysicists learned