OTC:ESALF

Eisai Commences Fully-Fledged Business Activities at Pharma Sales Subsidiary in South Africa

Retrieved on: 
Thursday, February 1, 2024

Commencement of Direct Sales Operations in Africa, and Establishment of Branch Office in Kenya

Key Points: 
  • Commencement of Direct Sales Operations in Africa, and Establishment of Branch Office in Kenya
    TOKYO, Feb 1, 2024 - (JCN Newswire) - Eisai Co., Ltd. announced today that fully-fledged operations have begun at Eisai Pharmaceuticals Africa (Pty) Ltd ("Eisai South Africa"), a pharmaceutical sales subsidiary recently established in Johannesburg, South Africa, and direct sales operations and business activities have commenced in Africa.
  • Eisai South Africa is a wholly-owned subsidiary of Eisai.
  • Eisai South Africa has started sales and marketing activities directly for Lenvima and Fycompa from January 2024, as well as Halaven from February 2024.
  • Seeking solutions to these challenges in Africa, Eisai will continue its initiatives to deliver necessary medicines to the patients who need them through Eisai South Africa and Eisai Kenya.

Eisai Submits New Drug Application for Mecobalamin Ultrahigh-Dose Formulation in Japan for the Indication of Amyotrophic Lateral Sclerosis

Retrieved on: 
Friday, January 26, 2024

TOKYO, Jan 26, 2024 - (JCN Newswire) - Eisai Co., Ltd. announced today that it has submitted a New Drug Application (NDA) for ultrahigh-dose mecobalamin (development code: E0302) for the indication of amyotrophic lateral sclerosis (ALS) to the Pharmaceuticals and Medical Devices Agency (PDMA) in Japan.

Key Points: 
  • TOKYO, Jan 26, 2024 - (JCN Newswire) - Eisai Co., Ltd. announced today that it has submitted a New Drug Application (NDA) for ultrahigh-dose mecobalamin (development code: E0302) for the indication of amyotrophic lateral sclerosis (ALS) to the Pharmaceuticals and Medical Devices Agency (PDMA) in Japan.
  • In May 2022, ultrahigh-dose mecobalamin received orphan drug designation by the Ministry of Health, Labour and Welfare (MHLW).
  • The results of JETALS were published in the peer-reviewed journal JAMA Neurology.
  • ALS is an intractable, progressive, neurodegenerative disease that results in severe muscle atrophy and weakness in the muscles due to motor neuron dysfunction.

Eisai: Antiepileptic Drug Fycompa Injection Formulation Approved in Japan

Retrieved on: 
Thursday, January 18, 2024

TOKYO, Jan 18, 2024 - (JCN Newswire) - Eisai Co., Ltd. announced today that it has obtained marketing authorization approval from the Japanese Ministry of Health, Labour and Welfare for the injection formulation of its in-house discovered antiepileptic drug (AED) Fycompa (perampanel) in Japan as an alternative therapy when oral administration is temporarily not possible.

Key Points: 
  • TOKYO, Jan 18, 2024 - (JCN Newswire) - Eisai Co., Ltd. announced today that it has obtained marketing authorization approval from the Japanese Ministry of Health, Labour and Welfare for the injection formulation of its in-house discovered antiepileptic drug (AED) Fycompa (perampanel) in Japan as an alternative therapy when oral administration is temporarily not possible.
  • Fycompa is a first-in-class AED discovered at Eisai's Tsukuba Research Laboratories.
  • Two oral formulations of Fycompa are available in Japan: a tablet and a fine granule formulation.
  • Since Fycompa is the only AMPA receptor antagonist-based AED, Eisai developed this injection formulation to meet the needs of patients who are unable to use oral administration, and filed a supplementary new drug application as a new route of administration in August 2022, leading to this approval.

Eisai Listed as a Global 100 Most Sustainable Corporation for the Eighth Time

Retrieved on: 
Wednesday, January 17, 2024

TOKYO, Jan 17, 2024 - (JCN Newswire) - Eisai Co., Ltd. announced today that it has been listed in the 2024 Global 100 Most Sustainable Corporations in the World (Global 100), a global ranking by Canada-based media and investment advisory company, Corporate Knights, Inc.

Key Points: 
  • TOKYO, Jan 17, 2024 - (JCN Newswire) - Eisai Co., Ltd. announced today that it has been listed in the 2024 Global 100 Most Sustainable Corporations in the World (Global 100), a global ranking by Canada-based media and investment advisory company, Corporate Knights, Inc.
  • Ranked 35th, Eisai is the highest ranking company among global pharmaceutical companies.
  • Also, Eisai became the highest ranking Japanese company among the three Japanese companies listed in the Global 100 (please visit here for the Global 100 ranking).
  • The Global 100 evaluates the sustainability of more than 6,700 of the world's major corporations based on various corporate initiatives in areas such as ESG (environment, society and governance).

Eisai Furthers Oncology Research Across Multiple Cancers at ASCO GI and ASCO GU 2024

Retrieved on: 
Tuesday, January 16, 2024

TOKYO, Jan 16, 2024 - (JCN Newswire) - Eisai Co., Ltd. announced today the presentation of oncology research at two upcoming medical meetings taking place in-person in San Francisco, California and virtually.

Key Points: 
  • TOKYO, Jan 16, 2024 - (JCN Newswire) - Eisai Co., Ltd. announced today the presentation of oncology research at two upcoming medical meetings taking place in-person in San Francisco, California and virtually.
  • First, the company will share findings in hepatocellular carcinoma (HCC) and cholangiocarcinoma during the 2024 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium (#GI24), which is taking place from January 18-20.
  • Tasurgratinib, for which a marketing authorization application was submitted in Japan in December 2023, is an orally available selective tyrosine kinase inhibitor of FGFR1-3.
  • Eisai aspires to discover innovative new drugs with new targets and mechanisms of action from these domains, with the aim of contributing to the cure of cancers.

Eisai: The Scientific Advisory Group (SAG) to Convene to Discuss the Marketing Authorization Application for lecanemab in the EU

Retrieved on: 
Thursday, January 11, 2024

TOKYO, Jan 11, 2024 - (JCN Newswire) - Eisai Co., Ltd. announced today that the Scientific Advisory Group (SAG) will convene to discuss the marketing authorization application (MAA) of lecanemab (generic name, brand name: LEQEMBI), which is currently under review by the European Medicines Agency (EMA).

Key Points: 
  • TOKYO, Jan 11, 2024 - (JCN Newswire) - Eisai Co., Ltd. announced today that the Scientific Advisory Group (SAG) will convene to discuss the marketing authorization application (MAA) of lecanemab (generic name, brand name: LEQEMBI), which is currently under review by the European Medicines Agency (EMA).
  • The meeting of the SAG is expected to take place during FY2023, which ends on March 31, 2024.
  • Eisai expects the European Commission's decision for the MAA of lecanemab in the first quarter of FY2024 ending June 30, 2024, if the opinion from the CHMP is received by March 31, 2024, following discussion by the SAG.
  • Eisai serves as the lead of lecanemab development and regulatory submissions globally with both Eisai and Biogen Inc. (U.S.) co-commercializing and co-promoting the product and Eisai having final decision-making authority.

Eisai: "LEQEMBI" (Lecanemab) Approved for the Treatment of Alzheimer's Disease in China

Retrieved on: 
Wednesday, January 10, 2024

Preparations for launch within the second quarter of Eisai's FY 2024 (July 1 - September 30, 2024) are underway.

Key Points: 
  • Preparations for launch within the second quarter of Eisai's FY 2024 (July 1 - September 30, 2024) are underway.
  • LEQEMBI is the first and only approved treatment shown to reduce the rate of disease progression and to slow cognitive and functional decline through this mechanism.
  • China is the third country to grant marketing approval, following the traditional approval in the U.S. in July 2023 and Japanese approval in September 2023.
  • ** An online business of Jingyi Weixiang (Shanghai) Health Industry Development Limited Company, a joint venture company with JD Health.

Development of Prediction Model for Brain Amyloid-Beta Accumulation Using Wristband Sensor

Retrieved on: 
Friday, December 29, 2023

TOKYO, Dec 29, 2023 - (JCN Newswire) - Oita University and Eisai Co., Ltd. (Eisai) hereby announce the development of the world's first machine learning model to predict amyloid beta*1 (Aβ) accumulation in the brain using a wristband sensor.

Key Points: 
  • TOKYO, Dec 29, 2023 - (JCN Newswire) - Oita University and Eisai Co., Ltd. (Eisai) hereby announce the development of the world's first machine learning model to predict amyloid beta*1 (Aβ) accumulation in the brain using a wristband sensor.
  • This model is expected to enable screening for brain Aβ accumulation, which is an important pathological factor of Alzheimer's disease*2 (AD), simply by collecting biological and lifestyle data from daily life.
  • The key to maximizing treatment effects of the medicine is detecting Abeta accumulation in the brain of patients with mild cognitive impairment before the onset of symptoms.
  • This machine learning model is able to predict brain Aβ accumulation using readily available non-invasive variables.