Care New England hospital gives 1st dose of Biogen Alzheimer's drug to patient not in a trial

A Care New England hospital became the first to administer Biogen's newly approved Alzheimer's drug, Aduhelm, to a patient outside a clinical trial, CNBC reported June 16. 

Butler Hospital in Providence, R.I., administered the drug to Marc Archambault, a 70-year-old man from Wakefield, R.I. 

Aduhelm, approved by the FDA June 7, targets a compound in the brain called a beta-amyloid, which scientists say plays a role in cognitive decline in Alzheimer's patients. It's the first drug to be approved to target cognitive decline caused by Alzheimer's and the first new Alzheimer's drug to be approved in 18 years. 

The drug is "transforming how we treat Alzheimer's," Stephen Salloway, MD, director of neurology at Butler Hospital, said at a news conference, according to CNBC

But the drug's approval has caused controversy. The FDA went against the advice of its independent panel of outside experts that declined to endorse the drug last year. Three members of the panel have resigned in protest of the FDA's decision to approve Aduhelm. 

Biogen stopped development of the drug in March 2019 after an analysis from an independent group found it was unlikely to work, CNBC reported. But several months later, Biogen announced it would seek approval of the drug, saying a new analysis of a larger dataset showed the drug "reduced clinical decline in patients with early Alzheimer's disease." 

The intravenous drug costs patients $56,000 per year and is expected to cost Medicare billions of dollars per year, according to CNBC

Some physicians have said they won't prescribe the drug due to the mixed results from clinical trials, CNBC reported. 

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