The exterior of the headquarters of biotechnology company Biogen in Cambridge, MA is pictured on March 21, 2019.
John Tlumacki | Boston Globe | Getty Images
A 70-year-old man from Rhode Island became the first person outside of a clinical trial to receive an infusion of Biogen’s newly approved Alzheimer’s drug Aduhelm on Wednesday.
Marc Archambault of Wakefield was treated with the intravenous drug – which costs a whopping $ 56,000 a year – during the memory and aging program at Butler Hospital in Providence, a spokesman confirmed to CNBC.
The drug “is changing the way we treat Alzheimer’s,” said Dr. Stephen Selloway, Director of Neurology and the Memory and Aging Program at Butler Hospital, at a news conference.
Biogen’s shares rose last week after the Food and Drug Administration approved the biotech company’s drug, the first US regulator-approved drug to slow cognitive decline in people with Alzheimer’s disease and the first new drug for the disease since almost two decades.
Biogen’s drug targets a “sticky” compound in the brain known as beta-amyloid that scientists expect to play a role in the devastating disease. The drug is expected to cost Medicare, which has not yet determined how much of the drug’s cost it will cover, billions of dollars a year.
Aduhelm from Biogen
Source: Biogen
The FDA’s decision was controversial as it departed from the advice of its independent panel of external experts, which unexpectedly declined to approve the drug last fall, citing inconclusive data. At least three members of the committee resigned in protest against the agency’s decision.
Dr. Aaron Kesselheim, professor of medicine at Harvard Medical School and one of three who stepped down, said the agency’s decision was “probably the worst drug approval decision in US recent history”.
“This will undermine the care of these patients, public trust in the FDA, the pursuit of useful therapeutic innovations, and the affordability of the health system,” he wrote upon stepping down from the FDA’s Advisory Committee on Peripheral and Central Nervous Systems.
Federal agencies have come under intense pressure from friends and family members of Alzheimer’s patients to speed up the drug scientifically known as aducanumab, but the road to regulatory approval has been controversial since it showed promise in 2016.
In March 2019, Biogen withdrew from development of the drug after analysis by an independent group found it was unlikely to work. A few months later, the company shocked investors when it announced that it would still have government approval for the drug.
When Biogen filed for approval for the drug in late 2019, its scientists said a new analysis of a larger data set showed that aducanumab “reduces clinical decline in patients with early-stage Alzheimer’s disease.”
Alzheimer’s experts and Wall Street analysts were immediately skeptical, wondering whether the clinical trial data was enough to prove the drug works and whether approval could make it difficult for other companies to enroll patients in their own drug trials.
Some doctors have said they won’t prescribe aducanumab because of the mixed data package that supports the company’s application.
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