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Eisai to Present Preclinical and Clinical Research on Eribulin at the 2022 San Antonio Breast Cancer Symposium

Retrieved on: 
Thursday, December 1, 2022
2019–2022 Sudanese transition to democracy, Eribulin, FDA, Research, Safety, EMBRACE, Senior, Breast cancer, Eisai, Pharmaceutical industry

TOKYO, Dec 1, 2022 - (JCN Newswire) - Eisai Co., Ltd. announced today that new study results on its in-house discovered and developed anticancer agent eribulin mesylate (HALAVEN, "eribulin") will be presented during the 2022 San Antonio Breast Cancer Symposium (SABCS), which is taking place virtually and in-person in San Antonio, Texas from December 6-10.

Key Points: 
  • TOKYO, Dec 1, 2022 - (JCN Newswire) - Eisai Co., Ltd. announced today that new study results on its in-house discovered and developed anticancer agent eribulin mesylate (HALAVEN, "eribulin") will be presented during the 2022 San Antonio Breast Cancer Symposium (SABCS), which is taking place virtually and in-person in San Antonio, Texas from December 6-10.
  • Eisai will present five eribulin-related abstracts, including a post hoc subgroup analysis from two pivotal Phase 3 studies (EMBRACE and Study 301), as well as:
    - Real world use of eribulin following treatment with a P13K inhibitor, mostly in people with Hormone Receptor (HR)-positive/HER2-negative metastatic breast cancer.
  • - Preclinical data exploring a liposomal formulation of eribulin, in a Phase 1 expansion cohort for breast cancer, versus eribulin at the same dose, in patient-derived breast cancer xenografts.
  • There is no guarantee that any investigational compounds or investigational uses of FDA-approved products will successfully complete clinical development or gain FDA approval.

Eisai Presents Full Results of Lecanemab Phase 3 Confirmatory Clarity Ad Study for Early Alzheimer's Disease at Clinical Trials on Alzheimer's Disease (CTAD) Conference

Retrieved on: 
Wednesday, November 30, 2022
Pathology, Hypertension, ADAS, PET, MCI, Positron emission tomography, Degenerative disease, Brain, ADCS, AD, Patient, Biogen, Biomarker, Apolipoprotein E, Diabetes, Confidence interval, Clarity, Alzheimer's disease, Kidney, Memantine, Cerebrospinal fluid, Trial of the century, CSF, Obesity, Medical imaging, Pharmaceutical industry, Eisai

Eisai's Clarity AD was a global confirmatory Phase 3 placebo-controlled, double-blind, parallel-group, randomized study in 1,795 people with early AD (lecanemab group: 898 placebo group: 897) at 235 sites in North America, Europe, and Asia.

Key Points: 
  • Eisai's Clarity AD was a global confirmatory Phase 3 placebo-controlled, double-blind, parallel-group, randomized study in 1,795 people with early AD (lecanemab group: 898 placebo group: 897) at 235 sites in North America, Europe, and Asia.
  • Eligibility criteria allowed patients with a broad range of comorbidities/comedications, including but not limited to hypertension, diabetes, heart disease, obesity, renal disease and anti-coagulants.
  • Lecanemab slowed decline of cognitive function by 26% on ADAS-Cog14 at 18 months (mean difference: -1.44 [95%CI: -2.27, -0.61]; P=0.00065).
  • In the ADCOMS assessment, lecanemab slowed disease progression by 24% at 18 months (mean difference: -0.050 [95% CI: -0.074, -0.027; P=0.00002]).

Eleven Experts from Leading Medical Institutions and Eight Experts from Eisai Publish Full Results of Lecanemab Phase 3 Confirmatory Clarity Ad Study for Early Alzheimer's Disease in the New England Journal of Medicine

Retrieved on: 
Wednesday, November 30, 2022
The New England Journal of Medicine, Brain, Trust, AD, Paper, Co-promotion, MCI, Trial of the century, Clarity, Safety, Alzheimer's disease, Pharmaceutical industry, Biogen, Eisai

The rapid publication of the Clarity AD study results demonstrates Eisai's strong commitment to trust and transparency based on Eisai's human health care mission.

Key Points: 
  • The rapid publication of the Clarity AD study results demonstrates Eisai's strong commitment to trust and transparency based on Eisai's human health care mission.
  • If approved, we will work to bring the drug expeditiously to people living with early AD and their families.
  • Eisai serves as the lead of lecanemab development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.
  • This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety.

Eisai Announces Approval of Partial Change to Label for Dosage and Administration of Aricept for Treatment of Dementia with Lewy Bodies

Retrieved on: 
Tuesday, November 29, 2022
Alzheimer's disease, Lewy body, Dementia, Eisai, Category, Safety, DLB, Category 2, Pharmaceutical industry, Donepezil

TOKYO, Nov 29, 2022 - (JCN Newswire) - Eisai Co., Ltd. announced that its application for a partial change to label for Aricept (donepezil hydrochloride), a treatment for Alzheimer's disease and dementia with Lewy bodies (DLB) that was discovered and developed in-house, regarding dosage and administration for the treatment of DLB in Japan, has been approved today.

Key Points: 
  • TOKYO, Nov 29, 2022 - (JCN Newswire) - Eisai Co., Ltd. announced that its application for a partial change to label for Aricept (donepezil hydrochloride), a treatment for Alzheimer's disease and dementia with Lewy bodies (DLB) that was discovered and developed in-house, regarding dosage and administration for the treatment of DLB in Japan, has been approved today.
  • (Please refer to "Notes to Editors" on the link below for details of the changes)
    This partial change to label is based on the results of a reexamination for the indication of "suppression of progression of dementia symptoms in dementia with Lewy bodies" of this drug, which was categorized as Category 2.
  • After receiving approval for the partial change in dosage and administration for DLB, Eisai will continue to place the highest priority on the provision of proper use and safety information for this drug, and will make continued contributions to address the diversified needs of, and increase the benefits provided to people living with DLB and their families.
  • For more information visit www.eisai.com/news/2022/news202282.html.