Biogen’s aducanumab was the last great hope for treating Alzheimer’s disease through an approach that the leading lights in the field have believed in for 30 years: siccing a lab-made monoclonal antibody on amyloid plaques in the brain. Now that aducanumab is back from the dead, with the company announcing on Tuesday that additional data overturned its earlier conclusion that the drug had no chance of working, the “amyloid hypothesis” also has a new lease on life — and Biogen has a potentially zillion-dollar moneymaker, should the Food and Drug Administration be persuaded.
Maybe. There are several things to watch for in the weeks and months ahead, and questions that will need to be answered. In no particular order:
Are more resurrections coming?
Biogen’s aducanumab trials were the first studies of an amyloid-targeting antibody to enroll only people with Alzheimer’s, whom it identified through amyloid-detecting brain imaging. Clinical trials of other antibodies, astonishingly, failed to do that, and one-third or more of patients didn’t even have what the antibody targeted. That raises a possibility that amyloid diehards have long suspected: that Eli Lilly’s solanezumab, Pfizer/Johnson & Johnson’s bapineuzumab, Roche’s crenezumab, and other anti-amyloid antibodies that had been left for dead didn’t get a fair test.
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