ADUHELM is indicated for the treatment of Alzheimer's disease. Treatment with ADUHELM should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. There are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied. This indication is approved under accelerated approval based on reduction in amyloid beta plaques observed in patients treated with ADUHELM. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s).
ICARE AD-US is a real-world study that will provide information on the long-term effectiveness and safety of ADUHELM as prescribed in routine clinical practice in the
The study design includes an important goal to help address the common underrepresentation of Black/
The study intends to enroll patients with Alzheimer's disease over four years from approximately 200 sites in the
"Biogen is committed to both generating new data about ADUHELM and supporting steps to bring adequate representation to this trial and other clinical trials from traditionally underrepresented groups," said
The ICARE AD-US study is one of three clinical programs designed to generate new data about ADUHELM. The others include EMBARK, the ongoing, Phase 3b re-dosing study for eligible patients previously enrolled in ADUHELM clinical trials, including the PRIME long-term extension, EMERGE and ENGAGE, and the confirmatory Phase 4 trial that is in the process of being designed and will be conducted to verify the clinical benefit of ADUHELM as part of the post-marketing requirements associated with the accelerated approval pathway of ADUHELM in the
"The ICARE AD-US study will provide important information on the safety, effectiveness and management of Alzheimer's disease with ADUHELM, the first approved treatment for Alzheimer's disease that targets the amyloid pathway, in the real-world setting across diverse populations," said
The presentation on the ICARE AD-US study will be available for 30 days on the AAIC conference website. Biogen will also post the presentation on the investors section of its website at investors.biogen.com.
For more information, visit https://www.eisai.com/news/2021/pdf/enews202164pdf.pdf.
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