June 17, 2021 -- A Rhode Island man received the first infusion of Biogen’s new Alzheimer’s drug on Wednesday, according to Reuters. The controversial drug drew criticism from some doctors after its FDA approval last week.

Mark Archambault, 70, of Wakefield, was the first person to take the drug outside of a clinical trial. He received the infusion, which is given as an IV as a monthly treatment, at Butler Hospital’s Memory and Aging Program in Providence.

“We are opening a new era in treatment,” Stephen Salloway, MD, director of neurology and the Butler Hospital program, told Reuters.

The FDA approved the drug, called Aduhelm and scientifically known as aducanumab, last week based on evidence that it can reduce brain plaques. The specific causes of Alzheimer’s aren’t fully known, the FDA said, but the disease leads to changes in the brain, such as amyloid plaques, that block neural connections and lead to memory loss.

Despite strong objections from its own independent advisory panel, the FDA approved Aduhelm for all patients with Alzheimer’s, though the drug has been tested only in patients with early stages of the disease. Three experts resigned from the advisory panel after the FDA decision, citing questionable clinical trial results and concerns about the potential side effects.

“Hopefully, clinicians will follow the clinical trial guidelines because we really don’t have any evidence for more advanced patients with Alzheimer’s,” Salloway said.

Federal regulators had faced pressure to fast-track the drug, according to CNBC. Friends and family members of Alzheimer’s patients have advocated for approval, though it has been a controversial topic since the drug showed promising results in 2016.

The cost of the drug has raised concerns as well. Cigna and other health insurance companies will likely cover the drug price only for patients with early Alzheimer’s, Reuters reported. Biogen, which has partnered with Japanese drugmaker Eisai Co., set an average price of $56,000 per year. The Alzheimer’s Association, which supports the FDA approval, called the price “simply unacceptable.”

“For many, this price will pose an insurmountable barrier to access, it complicates and jeopardizes sustainable access to this treatment, and may further deepen issues of health equity,” the association said in a statement.

Medicare hasn’t yet said how much of the price it will cover, though the drug is expected to cost Medicare billions of dollars a year. Even then, Medicare recipients are responsible for some portion of the cost of drugs, and some don’t have a limit on those costs, Reuters reported.

For Archambault, Butler Hospital will ask Medicare to cover the treatment, Salloway said. Despite the criticism of cost and clinical trial details, he said, hospitals across the country are preparing to administer Aduhelm since it is the first approved drug that could slow Alzheimer’s disease.

“All the major centers that have an interest in Alzheimer’s disease are taking this seriously,” he said.

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SOURCES:

Reuters: “First patient receives controversial Biogen Alzheimer’s drug.”

FDA: “FDA Grants Accelerated Approval for Alzheimer’s Drug.”

CNBC: “Patient receives first infusion of Biogen’s controversial Alzheimer’s drug.”

Alzheimer’s Association: “Next Steps for New Alzheimer’s Treatment.”

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