Tokyo:4523

"LEQEMBI" Lecanemab) Approved for the Treatment of Alzheimer's Disease in South Korea

Retrieved on: 
Tuesday, May 28, 2024

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.

Key Points: 
  • 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.
  • South Korea is the fourth country to grant approval, following approvals in the U.S., Japan, and China.
  • In South Korea, Eisai Korea Inc. will distribute the product and conduct information provision activities.
  • Eisai is committed to working together with healthcare professionals and other stakeholders to realize the early diagnosis and treatment of AD.

Eisai Showcases Oncology Portfolio and Pipeline at ASCO 2024

Retrieved on: 
Thursday, May 23, 2024

TOKYO, May 23, 2024 - (JCN Newswire) - Eisai Co., Ltd. announced today the presentation of research across multiple types of cancer from its oncology portfolio and pipeline during the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting (#ASCO24), which is taking place virtually and in-person in Chicago, Illinois from May 31 to June 4.

Key Points: 
  • TOKYO, May 23, 2024 - (JCN Newswire) - Eisai Co., Ltd. announced today the presentation of research across multiple types of cancer from its oncology portfolio and pipeline during the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting (#ASCO24), which is taking place virtually and in-person in Chicago, Illinois from May 31 to June 4.
  • 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 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.
  • (1) KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

Eisai: Metoject Subcutaneous Injection Pen (Methotrexate) Pen-Type Autoinjector Launched In Japan

Retrieved on: 
Wednesday, May 22, 2024

TOKYO, May 22, 2024 - (JCN Newswire) - Eisai Co., Ltd. and nippon medac Co., Ltd., a subsidiary of medac group announced today that they have launched the anti-rheumatic agent "Metoject Subcutaneous Injection 7.5mg Pen 0.15mL, 10mg Pen 0.20mL, 12.5mg Pen 0.25mL and 15mg Pen 0.30mL" (methotrexate, "MTX"), in Japan.

Key Points: 
  • TOKYO, May 22, 2024 - (JCN Newswire) - Eisai Co., Ltd. and nippon medac Co., Ltd., a subsidiary of medac group announced today that they have launched the anti-rheumatic agent "Metoject Subcutaneous Injection 7.5mg Pen 0.15mL, 10mg Pen 0.20mL, 12.5mg Pen 0.25mL and 15mg Pen 0.30mL" (methotrexate, "MTX"), in Japan.
  • Metoject Subcutaneous Injection Pen will be the first self-administrable MTX subcutaneous injection pen-type autoinjector for rheumatoid arthritis in Japan and was developed to reduce the burden on patients and improve safety during self- injection.
  • "By adding Metoject Subcutaneous Injection Pen to Eisai's product lineup, we are making further contributions to address the diversified needs of, and increase the benefits provided to, rheumatoid arthritis patients."
  • Product name: Metoject Subcutaneous Injection 7.5mg pen 0.15mL, 10mg pen 0.20mL, 12.5mg pen 0.25mL and 15mg pen 0.30mL
    Generic name: Methotrexate Indication for use: Rheumatoid arthritis Dosage and administration:
    The usual adult dose of methotrexate is 7.5mg injected subcutaneously once a week.

Eisai Initiates Rolling Biologics License Application to US FDA for LEQEMBI (lecanemab-irmb) for Subcutaneous Maintenance Dosing for the Treatment of Early Alzheimer's Disease Under the Fast Track Status

Retrieved on: 
Wednesday, May 15, 2024

If approved by the FDA, the LEQEMBI autoinjector could be used to administer LEQEMBI at home or at medical facilities.

Key Points: 
  • If approved by the FDA, the LEQEMBI autoinjector could be used to administer LEQEMBI at home or at medical facilities.
  • Eisai submitted to the FDA a Supplemental Biologics License Application (sBLA) for monthly LEQEMBI intravenous (IV) maintenance dosing in March 2024.
  • (2)
    LEQEMBI [(lecanemab-irmb) 100 mg/mL injection for intravenous use] is indicated for the treatment of Alzheimer's disease (AD).
  • LEQEMBI is contraindicated in patients with serious hypersensitivity to lecanemab-irmb or to any of the excipients of LEQEMBI.

Eisai: Research on Treatments for Alzheimer's Disease Based on Its Pathological Mechanisms Recieves Award for Science and Technology (Research Category)

Retrieved on: 
Thursday, April 18, 2024

TOKYO, Apr 18, 2024 - (JCN Newswire) - Eisai Co., Ltd. announced today that "The Research on Treatments for Alzheimer's Disease Based on its Pathological Mechanisms" has received the Award for Science and Technology (Research Category) as a part of the FY2024 Commendation for Science and Technology by the Minister of Education, Culture, Sports, Science and Technology.

Key Points: 
  • TOKYO, Apr 18, 2024 - (JCN Newswire) - Eisai Co., Ltd. announced today that "The Research on Treatments for Alzheimer's Disease Based on its Pathological Mechanisms" has received the Award for Science and Technology (Research Category) as a part of the FY2024 Commendation for Science and Technology by the Minister of Education, Culture, Sports, Science and Technology.
  • The Ministry of Education, Culture, Sports, Science and Technology (MEXT) grants this award to individuals who have made remarkable achievements regarding research, development, and knowledge enhancement in the field of science and technology, with the aim of encouraging those who engage in the field and raising the standard of Japanese science and technology.
  • This award is presented to individuals who have completed original research and development projects with high potential to contribute to the advancement of science and technology in Japan.
  • Prof. Takeshi Iwatsubo (Graduate School of Medicine and Faculty of Medicine, the University of Tokyo) Teiji Kimura (Global Alzheimer's Disease Head, Global Collaboration Network Lead, Senior Group Officer, Eisai Co., Ltd.)

Eisai's Antiepileptic Drug Fycompa Injection Formulation Launched In Japan

Retrieved on: 
Wednesday, April 17, 2024

TOKYO, Apr 17, 2024 - (JCN Newswire) - Eisai Co., Ltd. announced today that the injection formulation of its in-house discovered antiepileptic drug (AED) Fycompa (perampanel hydrate) for intravenous (IV) infusion has been launched in Japan.

Key Points: 
  • TOKYO, Apr 17, 2024 - (JCN Newswire) - Eisai Co., Ltd. announced today that the injection formulation of its in-house discovered antiepileptic drug (AED) Fycompa (perampanel hydrate) for intravenous (IV) infusion has been launched in Japan.
  • The injection formulation of Fycompa received manufacturing and marketing approval on January 18, 2024 and was included in the Japan's National Health Insurance (NHI) Drug Price List today.
  • 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 leading to the launch today.

French Sales Subsidiary Eisai S.A.S. to Divest Rights for Loxapac And Parkinane LP to CNX Therapeutics

Retrieved on: 
Wednesday, April 3, 2024

TOKYO, Apr 3, 2024 - (JCN Newswire) - Eisai Co., Ltd. announced today that its French sales subsidiary Eisai S.A.S.

Key Points: 
  • TOKYO, Apr 3, 2024 - (JCN Newswire) - Eisai Co., Ltd. announced today that its French sales subsidiary Eisai S.A.S.
  • entered into an agreement to transfer the rights in France, the French Overseas Territories and Algeria (the "Territory") for the antipsychotic, "Loxapac" (generic name: loxapine) and the Parkinson's disease treatment "Parkinane LP" (generic name: trihexyphenidyl hydrochloride) to CNX Therapeutics Limited.
  • Eisai anticipates no changes to its consolidated financial forecast for the period ending March 31, 2024.
  • acquired the rights to both treatments in the Territory in July 2002 and has been marketing them since.

Eisai Completes Submission of LEQEMBI (lecanemab-irmb) Supplemental Biologics License Application for IV Maintenance Dosing for the Treatment of Early Alzheimer's Disease to the U.S. FDA

Retrieved on: 
Monday, April 1, 2024

LEQEMBI is indicated for the treatment of Alzheimer's disease (AD) in patients with mild cognitive impairment or mild dementia stage of disease (collectively referred to as early AD).

Key Points: 
  • LEQEMBI is indicated for the treatment of Alzheimer's disease (AD) in patients with mild cognitive impairment or mild dementia stage of disease (collectively referred to as early AD).
  • Eisai had aimed to submit a Biologics License Application (BLA) for weekly maintenance therapy using subcutaneous (SC) administration in March 2024.
  • However, Eisai was recently informed by the FDA that a Fast Track designation specific for the SC formulation is needed to receive rolling review.
  • Treatment with LEQEMBI 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.

Eisai to Divest Rights for Merislon and Myonal in Japan to Kaken Pharmaceutical

Retrieved on: 
Friday, March 29, 2024

TOKYO, Mar 29, 2024 - (JCN Newswire) - Eisai Co., Ltd. announced today that it has entered into an agreement to divest its rights for vertigo and equilibrium disturbance treatment Merislon (generic name: betahistine mesilate) and muscle relaxant Myonal (generic name: eperisone hydrochloride) in Japan to Kaken Pharmaceutical Co., Ltd.

Key Points: 
  • TOKYO, Mar 29, 2024 - (JCN Newswire) - Eisai Co., Ltd. announced today that it has entered into an agreement to divest its rights for vertigo and equilibrium disturbance treatment Merislon (generic name: betahistine mesilate) and muscle relaxant Myonal (generic name: eperisone hydrochloride) in Japan to Kaken Pharmaceutical Co., Ltd.
    Merislon and Myonal have been widely used by patients in Japan for a long time since their launch in 1969 and 1983, respectively.
  • Eisai has determined that divesting rights for these products to Kaken, which has strengths in the products' disease areas, is the most optimal choice to ensure them to continue contributing to a greater number of patients.
  • Eisai anticipates no changes to its consolidated financial forecast for the period ending March 31, 2024.
  • Driven by our hhc concept, Eisai strives to create and deliver innovative products to target diseases with high unmet medical needs, with a particular focus in our strategic areas: Neurology, Oncology and Global Health.