Biogen submits study protocol for confirmatory phase IV ENVISION trial of Aduhelm to treat early Alzheimers' disease.
Biogen Inc. has submitted the final study protocol for the confirmatory Phase IV ENVISION trial to the FDA for review and approval.
This is in line with the company’s commitment to accelerate the timelines for the trial, including submitting the final study protocol to the FDA in March 2022, as previously announced. Biogen expects the first patient to enter screening in May 2022 and the trial’s primary completion approximately four years after the study begins.
The confirmatory ENVISION trial is a requirement based on FDA’s accelerated approval of Aduhelm (aducanumab-avwa) 100 mg/mL injection for intravenous use in early Alzheimer’s disease (Mild Cognitive Impairment due to Alzheimer’s disease and mild Alzheimer’s disease). The study, as previously announced, will be a global, placebo-controlled trial, aiming to enroll around 1,500 patients with early Alzheimer’s disease and confirmation of amyloid beta pathology.
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