|
| Friday, 30 July 2021, 08:24 HKT/SGT | |
| |  | |
Source: Eisai | |
|
|
|
|
- ICARE AD-US is an observational real-world phase 4 study designed to evaluate the safety and effectiveness of ADUHELM in clinical practice
- ICARE AD-US is one of three programs to generate post-approval data on ADUHELM, including the re-dosing Phase 3b EMBARK study and the planned confirmatory Phase 4 post-marketing requirement study
- Biogen aims to enroll at least 16 percent Latinx and Black/African American patients with Alzheimer's disease in the ICARE AD-US study as part of its commitment to increase participation from traditionally underrepresented communities |
TOKYO, July 30, 2021 - (JCN Newswire) - Biogen (Nasdaq: BIIB) and Eisai Co., Ltd. (Tokyo) today announced that Biogen led a late-breaking presentation on the design of the first real-world observational Phase 4 study in Alzheimer's disease called ICARE AD-US, at the Alzheimer's Association International Conference (AAIC), being held both virtually and in Denver, Colorado from July 26 - 30, 2021. ICARE AD-US, a prospective study of ADUHELMTM (aducanumab-avwa) 100 mg/mL solution for injection, is designed to collect real-world, long-term effectiveness and safety data on ADUHELM. The virtual oral session (#57522) was titled, "ICARE AD-US: design of a prospective, single-arm, multicenter, noninterventional real-world study of aducanumab in United States."
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 U.S. based on the label approved by the U.S. Food and Drug Administration (FDA). The primary objective of the study is to characterize and evaluate real-world, long-term changes in cognition, function and neuropsychiatric status in ADUHELM-treated patients. Secondary objectives are related to gaining a better understanding of ADUHELM safety in real-world clinical practice.
The study design includes an important goal to help address the common underrepresentation of Black/African American and Latinx patients in Alzheimer's disease studies, aiming to enroll at least 16 percent of the trial's expected 6,000 participants from these communities. Alzheimer's disease clinical trials commonly have one to two percent enrollment from these groups, even though Black/African Americans and Latinx people are respectively two and one-and-a-half times more likely than older White Americans to have Alzheimer's disease.
The study intends to enroll patients with Alzheimer's disease over four years from approximately 200 sites in the U.S. Patients will be monitored for a period of up to five years.
"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 Ivana Rubino, Ph.D., U.S. and Global Head of Medical, Alzheimer's Disease at Biogen. "We believe this can help us better understand the safety and effectiveness of treatment in patients with Alzheimer's disease across ethnicities, something that has challenged researchers in this field for decades. The ICARE AD-US study, designed in collaboration with Alzheimer's disease experts, underscores both of these commitments."
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 U.S.
"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 Harald Hampel, M.D., Ph.D., Vice President, Chief Medical Officer, Neurology Business Group, Eisai Inc. "It is important for Eisai and the larger scientific community to recruit patients of diverse ethnicities for clinical trials to help address health disparities."
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.
Topic: Press release summary
Source: Eisai
Sectors: BioTech
http://www.acnnewswire.com
From the Asia Corporate News Network
Copyright © 2025 ACN Newswire. All rights reserved. A division of Asia Corporate News Network.
|
|
|
|
|
|
|
| Eisai |
| July 31, 2025 17:27 HKT/SGT |
|
Revenue of LEQEMBI(R) (Preliminary Basis) |
| July 31, 2025 08:30 HKT/SGT |
Early Alzheimer's Patients Continue to Benefit from Four Years of LEQEMBI(R) (lecanemab-irmb) Therapy New Clinical Data Presented at AAIC
|
| July 31, 2025 08:20 HKT/SGT |
New Data Presented at AAIC Demonstrates Investigational LEQEMBI(R) (lecanemab-irmb) 360 mg Subcutaneous Maintenance Dosing Could Offer a New Option for Ongoing Treatment of Early Alzheimer's Disease
|
| July 31, 2025 08:10 HKT/SGT |
|
Two-Year Real-World Study of LEQEMBI(R) in the United States Presented at Alzheimer's Association International Conference (AAIC) 2025 |
| July 29, 2025 08:01 HKT/SGT |
|
LENVIMA(R) (lenvatinib) in Combination with Pembrolizumab and Transarterial Chemoembolization (TACE) Approved in China for the Treatment of Unresectable, Non-Metastatic Hepatocellular Carcinoma |
| July 25, 2025 12:31 HKT/SGT |
|
Eisai Listed for 24th Consecutive Year in FTSE4Good Index Series, an Index for Socially Responsible Investment |
| July 23, 2025 09:07 HKT/SGT |
|
Launch of Beova(R) Tablets in Thailand for Overactive Bladder |
| July 22, 2025 10:56 HKT/SGT |
|
Eisai To Present Four-Year Efficacy And Safety Data On Continuous Treatment With Lecanemab At The Alzheimer's Association International Conference 2025 |
| July 16, 2025 13:50 HKT/SGT |
|
Eisai Awarded "The 9th Bioindustry Award" for Drug Discovery Research for Anti- Amyloid B Monoclonal Antibody Lecanemab |
| July 14, 2025 09:20 HKT/SGT |
|
"URECE" (Dotinurad) Launched in China as a treatment for Gout |
| More news >> |
 |
|
|
|
