Jul 27, 2021 09:00 JST
Source: Eisai
|
|
Biogen and Eisai Announce ADUHELM (aducanumab-avwa) Data Presentations at Alzheimer's Association International Conference 2021
- Item-level analysis from EMERGE trial shows consistency in slowing decline across cognitive, functional and behavioral measures in early Alzheimer's disease - Presentations include an assessment of the correlation between reductions in amyloid beta and other biomarkers of Alzheimer's disease and clinical decline after treatment with ADUHELM - Presentation on ARIA data from Phase 3 trials provides insights for effective monitoring and management in real-world clinical practice
TOKYO, Jul 27, 2021 - (JCN Newswire) - Biogen (Nasdaq: BIIB) and Eisai Co., Ltd. (Tokyo, Japan) today announced that Biogen, as part of its Alzheimer's disease (AD) research portfolio, will contribute four virtual posters that showcase data from its clinical trials with ADUHELM (aducanumab-avwa) injection 100 mg/mL solution at the Alzheimer's Association International Conference (AAIC), being held in Denver, Colo. and virtually from July 26-30, 2021,
ADUHELM was recently granted accelerated approval by the U.S. Food and Drug Administration (FDA) as a treatment for 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).
The accelerated approval of ADUHELM has been granted based on data from clinical trials showing the effect of ADUHELM on reducing amyloid beta plaques, a surrogate biomarker that is reasonably likely to predict clinical benefit, in this case a reduction in clinical decline.
"Our presentations to the dementia research community at AAIC of this robust set of clinical trial data will allow us to engage directly with scientists and neurologists on in-depth analyses of our findings," said Alfred Sandrock, Jr., M.D., Ph.D., Head of Research and Development at Biogen. "We are looking forward to sharing our analyses on biomarkers, ARIA and safety management, the prespecified clinical endpoints in the Phase 3 ADUHELM trials and more."
"The clinical trial results Biogen shared about our joint asset, ADUHELM, at AAIC are important as we believe the data will help inform the scientific community as we continue to explore the strong scientific rationale behind the amyloid beta pathway as one of the earliest changes that occur in Alzheimer's disease," said Lynn Kramer, M.D., Chief Clinical Officer, Neurology Business Group, Eisai.
ADUHELM Poster Presentations
Item-level Analysis of Clinical Measures in Patients with Early Symptomatic Alzheimer's Disease Following Treatment with High-dose Aducanumab in the Phase 3 Study EMERGE
A poster presentation about item-level data from the EMERGE trial examines results on the individual items, or domains, that comprised the study's pre-specified endpoints measuring cognition, function and behavior. This analysis shows consistency of high-dose aducanumab treatment effect across these individual items and domains of the primary, secondary and tertiary clinical endpoints in the Phase 3 trial.
In this data set from EMERGE, treatment effects were observed across all six domains (three cognitive and three functional) measured by Clinical Dementia Rating-Sum of Boxes (CDR-SB), the primary endpoint of the trial. Secondary endpoints of the trial included change from baseline in the Alzheimer's Disease Assessment Scale - Cognitive Subscale (13 items) (ADAS-Cog13) and the Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory (Mild Cognitive Impairment version) (ADCS-ADL- MCI). Treatment effects were observed across ADAS-Cog13 items sensitive to cognitive change in early symptomatic Alzheimer's disease and across a broad range of items measuring ability to conduct activities of daily living, as measured by ADCS-ADL-MCI.
Treatment was also associated with a reduction in the behavioral and psychiatric symptoms of Alzheimer's disease, as measured by the Neuropsychiatric Inventory-10 (NPI-10), the tertiary efficacy endpoint of EMERGE.
These results are consistent with the results from the primary analysis of these pre-specified endpoints in EMERGE, endpoints that were selected to measure the broad array of cognitive, functional and behavioral symptoms experienced by individuals with Alzheimer's disease. The analysis concludes that, in EMERGE, treatment with high-dose aducanumab demonstrated reduced clinical decline evidenced by a statistically significant treatment effect on pre-specified primary and secondary clinical efficacy endpoints compared to placebo.
Reductions in Biomarkers of Alzheimer's Disease Pathophysiology Following Treatment with Aducanumab Were Associated with Slowing in Clinical Decline
A separate poster presentation examines whether an aducanumab-induced reduction in brain amyloid beta (Aβ) plaques and downstream biomarkers of Alzheimer's disease pathophysiology are associated with a slowing of clinical decline.
The authors assessed this through three analyses. The first, a group-level analysis, examined the association between treatment effect of aducanumab relative to placebo on brain Aβ plaque levels and clinical decline, as measured by amyloid positron emission tomography (PET) imaging and CDR- SB, respectively, across all aducanumab dose groups in the PRIME, EMERGE and ENGAGE clinical trials. Group-level analyses based on data from these trials demonstrated a positive association between aducanumab treatment effect on brain amyloid beta plaques and clinical measures across dose groups and studies, with the exception of the high-dose group from ENGAGE.
The second set of analyses assessed the relationship between treatment effects of aducanumab on brain Aβ plaque levels, downstream biomarkers of Alzheimer's disease pathophysiology and clinical measures in participant-level analyses. In EMERGE and PRIME, a greater reduction in brain Aβ plaque levels was associated with less decline across clinical endpoints in each study. In EMERGE, greater reduction in brain Aβ plaque levels was also associated with greater reduction in cerebrospinal fluid (CSF) markers of tau and neurodegeneration as well as less decline on clinical endpoints. Several of these relationships were not apparent in ENGAGE, in which a clinical treatment effect of aducanumab was not observed.
The third analysis showed that a smaller magnitude of clinical decline was observed in patients in PRIME, EMERGE and ENGAGE whose brain Aβ plaque levels were lowered to a threshold considered to be amyloid negative relative to patients who did not reach this threshold. Together, these results are consistent with the hypothesized mechanism of action of aducanumab and support a relationship between aducanumab-induced changes in biomarkers of Alzheimer's disease pathophysiology and slowing of clinical decline.
For more information visit https://www.eisai.com/news/2021/pdf/enews202162pdf.pdf.
Source: Eisai Sectors: BioTech
Copyright ©2024 JCN Newswire. All rights reserved. A division of Japan Corporate News Network.
|
Latest Release
Mitsubishi Power Begins Commercial Operation of Seventh M701JAC Gas Turbine in Thailand GTCC Project; Achieves 75,000 AOH To-Date Apr 24, 2024 17:19 JST
| MC and Denka Sign J/V Agreement in Fullerene Business Apr 24, 2024 17:02 JST
| Mitsubishi Motors Posts Record Sales in the Philippines in FY2023 Apr 24, 2024 13:56 JST
| NEC Develops High-speed Generative AI Large Language Models (LLM) with World-class Performance Apr 24, 2024 13:25 JST
| Fujitsu SX Survey reveals key success factors for sustainability Apr 23, 2024 10:25 JST
| Fujitsu and METRON collaborate to drive ESG success: slashing energy costs, boosting productivity with new manufacturing industry solutions Apr 22, 2024 16:09 JST
| NEC Strengthens Commitment to Space Industry with Investment in Seraphim Space Venture Fund II Apr 22, 2024 15:09 JST
| Soft Space Launches the First and Only JCB Payment Gateway in Malaysia Apr 22, 2024 15:00 JST
| TOYOTA GAZOO Racing takes a one-two in Croatian thriller Apr 22, 2024 10:47 JST
| First-ever Mazda CX-80 Crossover SUV Unveiled in Europe Apr 19, 2024 13:50 JST
| Fujitsu develops technology to convert corporate digital identity credentials, enabling participation of non-European companies in European data spaces Apr 19, 2024 10:17 JST
| Mitsubishi Heavy Industries and NGK to Jointly Develop Hydrogen Purification System from Ammonia Cracking Gas Apr 18, 2024 17:01 JST
| Toyota Launches All-New Land Cruiser "250" Series in Japan Apr 18, 2024 13:39 JST
| Fujitsu and Oracle collaborate to deliver sovereign cloud and AI capabilities in Japan Apr 18, 2024 11:14 JST
| Eisai: Research on Treatments for Alzheimer's Disease Based on Its Pathological Mechanisms Recieves Award for Science and Technology (Research Category) Apr 18, 2024 10:53 JST
| All-New Triton Confirmed as First Double-Cab Pickup Truck to Achieve 2024 Five-Star ANCAP Safety Rating Apr 18, 2024 09:22 JST
| Eisai's Antiepileptic Drug Fycompa Injection Formulation Launched In Japan Apr 17, 2024 16:17 JST
| Honda Unveils Next-generation EV Series for China Apr 17, 2024 12:15 JST
| Lexus presents Time at the 2024 Milan Design Week Apr 16, 2024 18:49 JST
| Mitsubishi Corporation Announces Participation in a DAC Project in Louisiana, USA Apr 16, 2024 14:36 JST
|
More Latest Release >>
|