WESTON (dpa-AFX) - Marc Archambault, a 70-year old man from Rhode Island, has become the first patient to receive Biogen Inc's (BIIB) newly approved and controversial Alzheimer's drug Aduhelm outside of a clinical trial on Wednesday.
Archambault received the infusion at Butler Hospital in Providence. The patient was diagnosed with mild cognitive impairment or early Alzheimer's disease.
'It's transforming how we treat Alzheimer's,' Dr. Stephen Salloway, director of the memory and aging program at Butler Hospital, said at a press conference. 'For those of you who don't know, it's a devastating disease.'
'Marc actually tried out for aducanumab [trials] twice but he flunked because he did too well on his memory tests,' Salloway said. 'We knew he had Alzheimer's and he was building up amyloid plaques in the brain and had an increased genetic risk for Alzheimer's.'
Last week, the FDA approved Aduhelm for the treatment for Alzheimer's, thus becoming the first drug to be approved in 18 years for the disease.
However, FDA's decision created controversy as the approval was given despite objections of its advisory Peripheral and Central Nervous System Drugs Advisory Committee.
Last November, the 11-member committee voted nearly in unison that the drug should not to be approved. The panel voted 0 yes, 10 no and 1 uncertain that it is 'reasonable' to consider the single phase III positive study, as primary evidence of effectiveness of Aducanumab for the treatment of Alzheimer's disease.
At least three members of the panel have resigned in protest of the agency's decision.
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