Japanese company Eisai has not rejected the possibility that its Alzheimer’s drug had a hand in the brain bleeds of two patients. The patients died during the trials but the company insists that the drug was not the cause of the deaths.
According to Eisai, the deaths could not possibly be directly credited to lecanemab, which is a drug used to decelerate cognitive decline in patients with early-stage Alzheimer’s by 27%. Lecanemab is being developed in collaboration with Biogen.
Both the patients who passed had taken blood-thinning medication and were elderly, one in his 80s and the other in her 60s. Knowing this Eisai told doctors to hold the risk-benefit dialogue with the caregivers before a prescription for patients taking anticoagulation medication.
Eisai stood by its monoclonal antibody therapy’s safety, which is the very first to reduce the rate of the condition’s progression in a big trial. It has raised expectations of a new treatment for the disease which is affecting over 50M people globally.
Ivan Cheung, the CEO of Eisai US said, “Our assessment is that these deaths cannot be attributed to lecanemab. Of course, we cannot rule out the possibility that lecanemab might have increased the susceptibility of bleeding risk in the brain.”
The results of the trial showed that 13 out of about 1,800 participants (Below 1%) died in the first year and a half of the trial. However, none of the fatalities were credited to lecanemab. 7 of the 13 deaths were of people in the placebo group.
Two deaths that were alarming for the investors took place during an extension period after the first 18 months. During this period lecanemab was administered in placebo group patients as well. Doctors have long been worried about the chance of swelling and bleeding in the brain due to monoclonal antibodies.
According to Eisai, one of the deaths was due to a brain hemorrhage, while the other cause of death was concluded as cardiopulmonary after autopsy. Vice-President of clinical research at Eisai, Michael Irizarry said that there were complicating aspects in both cases and lecanemab does not seem to be directly responsible for the deaths. However, he said that the possibility of its involvement cannot be ruled out.
Michael Irizarry also mentioned the need of discussing the benefit-risk concerning lecanemab use for people who are consuming or intend to start consuming anticoagulative medicine.
Hostile events befell 14% of the participants in the active drug group while 11.3% of the placebo group participants faced similar problems. Nearly one in six participants (16.7%) who were given the drug went through micro-bleeds in the brain compared to below one in ten (<10%) for the placebo group. Health experts who reviewed the results said longer trials are necessary to ascertain the safety and effectiveness of the drug.
University of California Los Angeles’ professor of neurology, Keith Vossel pointed out that in a trial with elderly participants, deaths were expected. He also said that the deaths may not become a barrier to the drug’s regulatory approval, but it could disturb the doctors’ perceptions of the drug’s safe use and subsequently it’s prescription.
