How Biogen’s Aduhelm Bet Became A Commercial Bust
Executive Summary
Biogen caught a lucky break in getting the first FDA approval for a potentially disease-modifying Alzheimer’s therapy, but doubt over clinical benefit and commercial missteps have left Biogen in a precarious position a year later.
You may also be interested in...
Tailored Alzheimer’s Indication Let Lecanemab Avoid Stronger Safety Warning, REMS
Eisai says ‘narrow’ indication negated need for REMS on amyloid-related imaging abnormalities and hemorrhages in the brain. Unusual nature of accelerated approval and confirmatory trial timing means safety data from the Phase III is barely mentioned in label.
Eisai Plots A Meticulous Path To Medicare Coverage For Lecanemab
Ivan Cheung, Eisai’s US CEO, explains the ‘question-by-question’ the company is taking to convince the Centers for Medicare and Medicaid Services that its Phase III Clarity AD results in Alzheimer’s offer the ‘high level of evidence’ needed for smooth reimbursement of lecanemab.
Biogen/Eisai’s Lecanemab Suggests A New Model For Accelerated Approval In The US
Why not wait for the confirmatory trial to read out before approval, at least in the context of an especially uncertain or controversial surrogate marker?