As U.S. regulators prepare to consider whether to approve the first new treatment for Alzheimer’s disease in two decades, the latest in a long line of failures has experts taking a closer look at the field’s only purported success.
In a clinical trial, two treatments from Eli Lilly (LLY) and Roche (RHHBY) failed to help patients with a rare, inherited form of the disease, the companies said Monday. Each drug relied on the theory that targeting a toxic brain plaque called amyloid can slow cognitive decline in Alzheimer’s. And thus the focus quickly shifted to Biogen (BIIB), which made global headlines last year after claiming a controversial victory with an amyloid-targeting therapy of its own. With that treatment expected to undergo Food and Drug Administration review this year, do the results from Lilly and Roche poke holes Biogen’s case for approval?