A third death has been tied to experimental Alzheimer's drug lecanemab, amplifying concerns about its safety, Science reported Dec. 21.
The 79-year-old Florida woman died in mid-September after experiencing extensive brain swelling and bleeding. Multiple Science neuroscientists reviewed her records and believe her death was likely caused by the antibody lecanemab, according to the report. The Florida woman had no obvious health problems other than her signs of early Alzheimer's disease, according to her medical records.
The newly revealed death follows reports of two other deaths possibly tied to the drug. Japanese drug manufacturer Eisai attributed the prior fatalities and brain injuries to factors unrelated to lecanemab and declined to comment on the Florida woman's death, citing patient privacy concerns.
"The failure of Eisai and [lecanemab co-developer] Biogen to disclose this case … is concerning and undermines my confidence that the reported safety data is complete," Matthew Schrag, MD, PhD, neurologist and neuroscientist at Nashville, Tenn.-based Vanderbilt University, told Science.
Eisai has reported 13 deaths in the core clinical trial, which involved about 1,800 people. However, no details of the deaths have been made public, so scientists have been unable to assess whether lecanemab contributed to the fatalities or if they were due to other health issues.