Biogen - Eisai Launch 5-Year Study To See How Well Alzheimer's Drug Aduhelm Works In Real World - Eisai Co (OTC:ESALF), Biogen (NASDAQ:BIIB)

Biogen Inc BIIB and Eisai Co Ltd 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.
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