Biogen - Eisai Launch 5-Year Study To See How Well Alzheimer's Drug Aduhelm Works In Real World
- Biogen Inc (NASDAQ: BIIB) and Eisai Co Ltd (OTC: ESALY) launched a real-world, Phase 4 study to evaluate the long-term effects of the Aduhelm (aducanumab-avwa) 100 mg/mL solution for injection this time, with a focus on recruiting more patients from minority groups.
- The companies are looking for 6,000 Alzheimer’s patients with mild cognitive impairment or mild dementia to participate in an observational study dubbed ICARE AD-US.
- After taking Aduhelm, patients in the study will be monitored roughly every six months for a total of five years, as researchers look for changes in cognition, function, and neuropsychiatric status.
- Researchers will also look at how Aduhelm impacts healthcare resources, quality of life, and overall disease burden.
- The companies have also committed to enrolling at least about 1,000 Black and Latinx patients, or a combined 16% of the total study group.
- ICARE is one of three post-approval studies that Biogen is planning for Aduhelm, including an ongoing re-dosing study for patients previously enrolled in Aduhelm trials. The confirmatory Phase IV trial is still being designed.
- Price Action: BIIB shares are down 0.22% at $328.45 during the market session on the last check Friday.
- Photo by Gerd Altmann from Pixabay
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