Drugs

Biogen Probes Fatal Case of Aduhelm Patient

Biogen says it is investigating the death of a 75-year-old patient who had taken the company’s controversial Alzheimer’s drug Aduhelm (aducanumab). An email statement provided to FDA Webview said there is no confirmation the death is related to Aduhlem as it is still under investigation. The patient was diagnosed during hospitalization with cerebral edema thought to be amyloid-related imaging abnormalities (ARIA), according to the statement.

Aduhelm was granted accelerated approval earlier this year amid a firestorm of criticism over the agency’s use of the pathway for an Alzheimer’s indication (see earlier story). Three FDA advisory committee members who were on a panel that voted 10-0-1 last November not to recommend the drug’s approval have resigned their agency posts in protest.

Biogen’s statement says the company “continuously monitors all sources of safety information, including the reports published on the FDA Adverse Event Reporting System (FAERS) Public Dashboard, which is updated quarterly and contains adverse events reports, medication error reports, and product complaints. All the recently published cases related to Aduhelm are under careful review... We continue to work with the reporting physician as well as global regulators to further understand the case. Alzheimer’s disease is complex, and patients affected by this devastating disease often suffer from other serious medical conditions.”

Additionally, Biogen says that in its Phase 3 clinical studies, 0.3% of Aduhelm-treated patients reported serious symptoms associated with ARIA that did not result in death. “Reported causes of death in aducanumab clinical trials were consistent with those that are common in patients with Alzheimer’s disease and with other serious medical conditions for the study age population,” the company says.

Biogen says it continues to believe that the potential benefits of Aduhelm outweigh potential risks, despite a death under investigation.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome