An elderly patient died after being treated with Biogen's Alzheimer's disease drug Aduhelm

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Since its approval, clinicians have always had reservations about Biogen's controversial Alzheimer's (AD) antibody drug Aduhelm (aducanumab)

According to the latest case summary report received by the US FDA as of the end of September, the FDA's Adverse Event Reporting System (FAERS) recorded a patient who died after receiving Aduhelm treatment

Bojian said in an email responding to a request for comment: “All recently announced cases of side effects related to Aduhelm are “under scrutiny and medical evaluation,” including deaths

ARIA is a known side effect of Aduhelm and other similar antibody drugs that target toxic amyloid plaques in the brain

At the dose recommended by the FDA, Aduhelm may cause ARIA cases, which has been learned from its clinical trials

In addition to the death cases, the FAERS project also recorded another 3 new ARIA cases between July and September

Bojian has found that the incidence of Aduhelm's ARIA is increased in APOE-4 gene carriers

Brian Abrahams pointed out that although Aduhelm has known ARIA risks, it is still too early to draw a causal relationship between recent deaths and Aduhelm

Brian Abrahams pointed out that if the death was indeed caused by Aduhlem, this may highlight that ARIA is a real adverse event that can lead to negative outcomes

Brian Abrahams said that the ARIA question “explains why doctors may be more conservative when prescribing for the first time until they have accumulated experience of benefiting risks, even if there is more access to medicines”

And due to the general caution of clinicians, Aduhelm's sales in the third quarter of this year were only $300,000, which was far below the already sluggish expectations of industry observers

Reference source: Biogen's Aduhelm records one patient death.