ESALY.PQ

Biogen and Eisai Announce ADUHELMTM (aducanumab-avwa) Data Presentations at Alzheimer's Association International Conference 2021

Tuesday, July 27, 2021 - 1:00am

There are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied.

Key Points: 
  • 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).
  • Several of these relationships were not apparent in ENGAGE, in which a clinical treatment effect of aducanumab was not observed.

Eisai: FDA Approves LENVIMA (lenvatinib) Plus KEYTRUDA (pembrolizumab) Combination for Patients With Certain Types of Advanced Endometrial Carcinoma

Friday, July 23, 2021 - 1:17am

Based on the type and/or severity of the adverse reaction, LENVIMA may be interrupted, reduced and/or discontinued.

Key Points: 
  • Based on the type and/or severity of the adverse reaction, LENVIMA may be interrupted, reduced and/or discontinued.
  • Based on its mechanism of action and data from animal reproduction studies, LENVIMA can cause fetal harm when administered to a pregnant woman.
  • Based on the severity of the adverse reaction, KEYTRUDA should be withheld or permanently discontinued and corticosteroids administered if appropriate.
  • "Based on Phase 3 data, today's approval acts as the confirmatory trial to our previous accelerated approval of KEYTRUDA plus LENVIMA in patients with certain types of advanced endometrial cancer and reinforces the impact of our joint research with Eisai in exploring the potential of this combination to treat more patients with challenging types of cancer."

Eisai to Present Latest Data on Pipeline Assets in The Area of Alzheimer's Disease and Dementia at AAIC 2021

Wednesday, July 21, 2021 - 2:34am
Key Points: 
  • A poster presentation will also be given on the results of an in vivo study of E2511, Eisai's in-house discovered and developed investigational novel oral synapse regenerant.
  • Additionally, Eisai and Biogen Inc. (Nasdaq: BIIB) will hold a virtual symposium, "Defining the next-generation clinical care pathway for Alzheimer's disease: biological, technological, and healthcare perspectives," focusing on the AD treatment landscape.
  • Eisai serves as the lead in the co-development of lecanemab, an anti-Aβ protofibril antibody, which is being jointly developed by Eisai and Biogen.
  • Eisai aims to realize the prevention and cure of dementia through a multi-dimensional and holistic approach with a foundation of over 35 years of experience of drug discovery activities in the area of AD and dementia.

Eisai Launchs Bile Acid Transporter Inhibitor Goofice in Thailand

Monday, July 19, 2021 - 1:03am

TOKYO, July 19, 2021 - (JCN Newswire) - Eisai Co., Ltd. announced that its Thailand subsidiary Eisai (Thailand) Marketing Co., Ltd. has launched the bile acid transporter inhibitor Goofice (generic name: elobixibat hydrate) in Thailand.

Key Points: 
  • TOKYO, July 19, 2021 - (JCN Newswire) - Eisai Co., Ltd. announced that its Thailand subsidiary Eisai (Thailand) Marketing Co., Ltd. has launched the bile acid transporter inhibitor Goofice (generic name: elobixibat hydrate) in Thailand.
  • Goofice inhibits the bile acid transporter that regulates reabsorption of bile acids thereby increasing the flow of bile acids to the colon.
  • In Asia (Thailand, Indonesia, Philippines, Malaysia, and Singapore), Eisai is responsible for the commercialization and marketing of this product under a contract with EA Pharma.
  • Eisai will continue to make a further contribution to improve QOL for patients with chronic constipation in Thailand and other Asian countries, through maximization of the product value of Goofice.