Last Updated: Jan 04, 2023

A third patient death has taken place that has been potentially linked to Eisai and Biogen’s Alzheimer’s disease medication known as Lecanemab. As per the report, the death occurred in the phase 3 extension study. The woman who died recently was enrolled in the extension portion of the phase 3 trial of the Alzheimer’s disease drug. Experts have found that she was suffering from brain swelling and bleeding, and seizures as well.

She was a 79-year-old woman from Florida. The officials from Eisai have declared the death of the third patient, however, they have refused to give exact data on the patient citing a pledge to privacy for patients who have been enrolled in clinical trials. The officials have also said that details generated from other sources outside of scientific trials might not have all the necessary data to make a correct conclusion. A spokesperson from Eisai has stated that any evaluation of mortality or deaths should ponder upon the age of participants who have participated in the clinical trial, their other underlying medical conditions, and the length of the study as well.

The officials of the firm have said that the rate of mortality and the causes of death, which have been seen in Lecanemab clinical trials are in line with the estimated rate of deaths among people who are in the age range and observation that has been seen in the long-term Aricept studies. Aricept is the first Alzheimer’s drug from Eisai that was authorized in the United States in 1997. Aduhelm was the second Alzheimer’s drug developed by Biogen and Eisai. It was authorized in 2021 under the fast-tracked review pathway.

The officials of the company have claimed that the rate of mortalities that have been seen in the Lecanemab clinical trial is parallel to the placebo group study. It does not reflect an increase in overall deaths. Two other patients as well have lost their lives and their deaths have been linked to a standard side effect of this category of medication that is known as amyloid-related imaging abnormalities (ARIA).  Such abnormalities can be usually identified in MRI imaging and can lead to bleeding and swelling in the brain.

Health experts have said that these mortalities have overshadowed the success of Lecanemab in phase 3 clinical trials. Such drugs are a kind of a rarity for Alzheimer’s treatment. In September, the officials from Eisai claimed that the treatment was able to reduce cognitive decline in the phase 3 Clarity AD trial. They said that the findings of the trials and other data would be required to obtain a potential regulatory approval.

The concealment of information on the third person who died during the Clinical Trials on Alzheimer’s Disease has been heavily criticized by Eisai. Officials from both firms responded to criticism by saying that safety data and serious incidents arising from clinical trials are reported as quickly as possible to FDA. The company has stated that it is committed to publishing all data in peer-reviewed journals in an appropriate scientific manner.

The company refused to acknowledge that ARIA is the cause of the latest death and stated that it has not been reported to the CTAD conference. The company has not provided hospital records to experts investigating the latest death. The clinical trial extension is ongoing and adverse incident data have not yet been confirmed. Seven patients were affected by severe adverse events due to ARIA in phase 3. These cases were fixed. Eisai reported 25 cases of symptomatic cerebral swelling. This condition is known as ARIA-E.