Biogen investigating death of patient taking Alzheimer's drug

Pharmaceutical company Biogen is investigating the death of a patient who had taken the company's controversial Alzheimer's drug Aduhelm, though it is not yet clear if there is any link. 

The death of the 75-year-old woman in Canada was reported and published in the Food and Drug Administration's (FDA) quarterly adverse event reporting dashboard. The patient was hospitalized after taking Aduhelm and was diagnosed with swelling in the brain before dying, the company said in a statement Wednesday.

"All the recently published cases related to Aduhelm are under careful review as well as medical evaluation, including the fatal case," Biogen said. "We continue to work with the reporting physician as well as global regulators to further understand the case."

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While the exact cause of death remains under investigation, Biogen said, it is thought to be a result of the brain swelling and bleeding.

Aduhelm targets and is meant to reduce built-up deposits of brain plaque, which is thought to be a contributor to Alzheimer's disease.

A brain-swelling condition called ARIA-E is a known side effect of the drug, and the FDA recommended monitoring patients for symptoms before and during treatment. 

According to the company, 35 percent of patients in the two late-stage clinical trials had ARIA-E, making it the most common adverse event. 

However, 98 percent of the cases were resolved over the course of the trials, and the company on Wednesday said just 0.3 percent of patients treated with the FDA-recommended dose reported serious symptoms associated with ARIA-E; none of them resulted in death.

It's too early to draw a conclusion definitively linking the death with Biogen's drug, and the company noted the mere presence of a report in the FDA's database is not an indicator of the safety profile of the drug or biologic. 

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But there were concerns among experts that Biogen didn't have data showing ARIA-E was not a long-term threat. Those concerns, along with questions about the overall efficacy of the drug, led to objections over the FDA's decision to fast-track its approval in early June.

Aduhelm was the first new Alzheimer's drug approved in nearly 20 years, but the approval came over the nearly unanimous objection of the FDA's expert advisory committee. Three of the agency's outside advisers resigned over the decision.

Since the approval, the company has been battling slow uptake. Aduhelm costs $56,000 over the course of treatment; the company reported only $300,000 in sales. 

Aduhelm is not a cure for Alzheimer's, and the FDA made its decision without clear evidence that the drug can even slow the progression of the disease.

"No medicine is without risk, and we believe that the potential benefits of Aduhelm continue to outweigh potential risks," the company said.