Biogen Probes Patient Death Possibly Linked to Aduhelm

Biogen is investigating the death of a 75-year-old patient from cerebral edema that was possibly related to the antiamyloid antibody Aduhelm.

In an emailed response to FDAnews, the company noted that the review is ongoing. The drug was expected to be a blockbuster for Biogen, but sales have been disappointing in its first few months on the market, possibly because the annual cost of the drug is $56,000 and there is some uncertainty over what portion of that Medicare might pay.

The patient developed the condition, known as amyloid-related imaging abnormality-edematous (ARIA-E). This well-documented reaction is not uncommon in this class of antibodies; however, the syndrome is typically mild-to-moderate and self-limiting. Cases can also be silent, only diagnosed by incidental brain imaging.

“All of the recently published cases related to Aduhelm are under careful review as well as medical evaluation, including the fatal case of a 75-year-old patient whose cause of death remains under investigation,” the email said. “[The patient] was diagnosed during hospitalization with cerebral edema thought to be ARIA-E.”