Concerns raised about new Alzheimer’s drug

Concerns about safety risks of the controversial new Alzheimer’s drug Aduhelm have intensified in the wake of the death of a 75-year-old woman who experienced brain swelling after receiving infusions of the drug as a participant in a clinical trial.

The death of the woman, who lived in Canada, occurred in late September and was reported by a doctor to the Food and Drug Administration’s adverse event reporting system this summer. It is being investigated by both the FDA and Biogen, which makes the drug, also known by its scientific name, aducanumab.

In a statement Biogen said, “The cause of death is unknown at this time. We know the 75-year-old clinical trial patient was admitted to the hospital with a seizure” and diagnosed with brain swelling.

“Following a prolonged hospitalization, the patient was being prepared for discharge when she deteriorated and was transferred to another facility,” the statement continued. “We have requested missing information, including brain imaging, from the critical last nine days of hospitalization.”

Last week, Brian Abrahams, a biotech analyst with RBC Capital Markets who has a medical degree, wrote to clients that he had obtained the woman’s case report through a public records request and had concluded that the brain swelling probably caused the woman’s death and “that this is likely to have been caused by aducanumab.”

In its statement, Biogen said that “the RBC report only provides a partial view of the case,” adding, “We take this event very seriously and continue to work with the reporting investigator.”

In a note earlier this month, Abrahams, whose assessments of the case were reported previously by Endpoints News, Fierce Pharma and other publications, wrote that the report suggested that the patient “did not appear to have any other contributing conditions listed.”

Brain swelling and brain bleeding are known to be possible side effects of Aduhelm, a monoclonal antibody that is administered as a monthly infusion. The FDA approved the drug in June even though a council of senior FDA officials, an advisory committee of outside experts and many Alzheimer’s specialists said it was unclear whether Aduhelm could benefit patients and the drug carried serious risks of harm.