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Biogen promises increased diversity in Phase 4 Aduhelm trial

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The drug was approved by the FDA last year as a 100mg / mL injection for intravenous use in early Alzheimer’s disease: with the FDA requiring a further clinical trial to verify the drug’s clinical benefit.

Patient screening for the’Envision’ trial is planned for May 2022. The primary completion date is expected to be approximately four years after the study begins.

Diversifying populations

Biogen aims to enroll 18% of US participants in the trial from Black / African American and Latinx populations.

“Historically, patients from diverse backgrounds have been poorly represented in Alzheimer’s disease clinical trials, and we are committed to changing this,”Said Priya Singhal MD, MPH, Head of Global Safety & Regulatory Sciences and interim Head of Research & Development at Biogen..

“This goal matches the diversity among Americans diagnosed with early Alzheimer’s disease, while at the same time, the trial will generate substantial data to verify the effectiveness of Aduhelm.”

Biogen says it has multiple strategies to help overcome barriers to diverse patient enrollment in Alzheimer’s disease trials, such as the lack of access to medical centers, familiarity with benefit / risk profile of treatment, and financial or logistical burdens.

The Global Alzheimer’s Platform Foundation estimates that clinical trials of Alzheimer’s therapeutics usually only include around 2-3% African American and Latino individuals. It applauds Biogen’s 18% ambition, saying this should become a baseline goal across clinical trials.

Sources

1/ https://Google.com/

2/ https://www.biopharma-reporter.com/Article/2022/01/31/biogen-promises-increased-diversity-in-phase-4-aduhelm-trial

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