Biogen said Thursday that it expects to begin a large clinical trial next May to confirm the benefits of the Alzheimer’s disease treatment Aduhelm, pending clearance from U.S. regulators.
The trial, a condition of Aduhelm’s Food and Drug Administration approval, could answer some outstanding questions that have kept many neurologists from prescribing Biogen’s drug. But it’ll be years before the company has data to show.
The study will enroll more than 1,300 patients with early-stage Alzheimer’s from the U.S. and internationally, Biogen said, comparing Aduhelm to placebo over the course of 18 months. Other details about the trial design, including endpoints, are not being disclosed at this time, a spokesperson added.
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