Update on the phase IV ENVISION confirmatory study of Aduhelm.

Biogen aims to enroll 18 percent of U.S. participants in ENVISION from Black/African American and Latinx populations. This goal is reflective of Biogen’s ongoing commitment to increase diversity in clinical trials.

The companies also announced that the primary endpoint for the global, placebo-controlled ENVISION trial will be measured by the Clinical Dementia Rating–Sum of Boxes (CDR-SB) at 18 months after treatment initiation with Aduhelm. The CDR-SB endpoint is a validated measure of both cognition and function that is widely used in clinical trials of patients with early symptomatic Alzheimer’s disease, is consistent with Aduhelm’s Phase III EMERGE and ENGAGE studies, and capable of generating robust outcomes. The update also includes an increase in the previously announced enrollment, from 1,300 to 1,500 people with early Alzheimer’s disease (Mild Cognitive Impairment due to Alzheimer’s disease and mild Alzheimer’s disease), with confirmation of amyloid beta pathology, to further strengthen the data provided by the study.

Although ENVISION and other Aduhelm clinical trials are already planned or underway, the Centers for Medicare and Medicaid Services (CMS) recently released a draft National Coverage Determination (NCD), which would restrict Medicare coverage of Aduhelm and other amyloid-targeting therapies to patients enrolled in an additional clinical trial. Biogen is committed to engaging with CMS to avoid unnecessary duplication of clinical trials and work towards finding a path to offer immediate access to patients to the first FDA approved treatment for Alzheimer’s disease since 2003. In addition to the primary endpoint, CDR-SB, secondary endpoints include Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog 13), Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory - Mild Cognitive Impairment Version (ADCS-ADL-MCI), Integrated Alzheimer's Disease Rating Scale (iADRS), Mini-Mental State Examination (MMSE) and Neuropsychiatric Inventory (NPI-10).

The initiation of patient screening for ENVISION is planned for May 2022. Based on enrollment rates from the previous Phase III trials with Aduhelm, the primary completion date is expected to be approximately four years after the study begins. The companies are grateful to the healthcare professionals, medical centers, patients and families who will participate in this trial. Previously, in July 2021, the companies set another substantial diversity goal in the observational Phase IV ICARE AD trial, which aims to enroll a total of approximately 6,000 patients.