Third Patient Fatality Prompts Urgent Calls for FDA Action Ahead of Lecanemab Decision

As the FDA nears its decision on Biogen and Eisai’s lecanemab, a new potential death linked to the Alzheimer’s drug has been revealed in a letter published Wednesday in the New England Journal of Medicine – just two days away from the FDA’s conclusion.

Nicholas J. Reish, M.D., Ph.D. and other physicians at Northwestern recently wrote a letter to the editor about a 65-year-old patient with early Alzheimer’s. This patient had bravely participated in a randomized Phase III Clarity-AD trial, and subsequently received three intravenous infusions of the anti-amyloid antibody in the open-label phase. This case study reveals the potential of medical treatments for Alzheimer’s and the dedication of its patients in finding a cure.

The autopsy report revealed a cerebrovascular disorder known as cerebral amyloid angiopathy (CAA), in which small-to-medium-sized cerebral blood vessels and meninges become clogged with amyloid beta-peptide. This condition can have a significant impact on brain function and can lead to a range of neurological symptoms.

The patient tragically succumbed to a stroke, despite being administered the emergency stroke-busting medication, t-PA, via intravenous injection. Unfortunately, the patient suffered numerous acute intracerebral hemorrhages, leading to their untimely death.

The authors noted that the sheer volume and range of sizes of the cerebral hemorrhages observed in this patient was out of the ordinary when related solely to cerebrovascular amyloid and t-PA.

The results of this study suggest that a combination of t-PA infusion and lecanemab may be linked to cerebral hemorrhaging and necrotizing vasculopathy in patients with cerebrovascular amyloidosis. This is a potentially concerning finding that requires further research and investigation.

The case of the patient with early-onset Alzheimer’s disease reported in the New England Journal of Medicine has generated crucial questions about management for those who are homozygous for the APOE ε4 allele. In response, Drs. Marwan Sabbagh and Christopher H. van Dyck of the Barrow Neurological Institute and the Yale School of Medicine respectively have acknowledged the importance of this issue.

At the 2022 Clinical Trials on Alzheimer’s Disease (CTAD) conference in November, Dr. Stephen Sabbagh made a presentation on Clarity-AD, during which he addressed two deaths that had previously been linked to lecanemab. His insights were powerful and thought-provoking, and provided a valuable perspective on the potential risks and benefits of this treatment.

The tragedy of two deaths linked to lecanemab, a drug developed by Clarity-AD, was brought to light just days before its presentation at the CTAD conference. In October, an unidentified Clarity-AD investigator attributed a patient’s death to the drug, while in the following month, a report in Science connected a second patient’s death to lecanemab. Both of these fatalities were caused by intracranial hemorrhage.

Sabbagh and Dyck highlighted the possible role of high blood pressure and vasculitis in the death of the stroke patient, in addition to the administration of t-PA. They also noted how fatal intracerebral hemorrhages have occurred in people with CAA who were not taking anti-amyloid medications, even when t-PA was administered.

Biogen and Eisai are anxiously awaiting their appointment with the FDA on Jan. 6, and have their fingers crossed for a successful outcome. BioSpace has reached out to Eisai for additional comment and will update readers accordingly.

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