US major Biogen’s (NASDAQ: BIIB) Alzheimer’s disease (AD) therapy aducanumab has been administered to a Chinese patient for the first time via the Hainan branch of Ruijin Hospital. The hospital is part of the Boao Lecheng medical pilot zone in Hainan province.
Aducanumab: FDA Approval and Indication
Aducanumab, a beta amyloid protein antibody, won a fast-track approval in the US in June last year, becoming the first and only FDA-approved drug for Alzheimer’s in two decades. The approved indication was to treat patients with mild cognitive impairment or mild dementia, and was based on the Phase III EMERGE trial. The results of the trial have shown that aducanumab can effectively remove 71% of beta amyloid plaques, significantly delaying the decline of patients’ cognitive ability (delaying the decline of CDR-SB score by 22%), so that patients can maintain longer independent living ability. The clinical decline of patients with decreased plasma p-tau181 level at the 78th week was smaller than that of patients without decreased plasma p-tau181 level.
Controversy Surrounding Approval
However, the approval was met with controversy. A US FDA panel of experts voted against the drug’s approval but was ignored by the FDA. The entire thesis that clearing amyloid plaques can be used as an alternative endpoint for the treatment of Alzheimer’s disease was called into question by those experts.-Fineline Info & Tech
