The FDA approved Aduhelm on June 7 via its accelerated pathway, sparking debate in the healthcare community among critics who say there is not enough scientific evidence that the drug works, and that there is evidence it can have severe side effects on the brain.
Biogen told Endpoints News it is reviewing all adverse events reports, medication error reports and product complaints published in FDA’s adverse event reporting system. The drugmaker said the 75-year-old patient was “diagnosed during hospitalization with cerebral edema thought to be ARIA-E,” and the cause of death remains under investigation.
“We continue to work with the reporting physician as well as global regulators to further understand the case,” Biogen said. “Alzheimer’s disease is complex, and patients affected by this devastating disease often suffer from other serious medical conditions.”
During the two trials used for Aduhelm’s approval, ARIA-E was the most common adverse event. More than 80 percent of ARIA-E events from the trials were reported as resolved within 16 weeks.
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