Tag: Eisai

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

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 ... Read more

Japan – Eisai to Divest Rights for Muscle Relaxant Myonal, Vertigo, and Equilibrium Disturbance Treatment Merislon in Asia to DKSH

Eisai Co., Ltd. announced today that it has entered into an agreement to divest its rights for muscle relaxant Myonal (generic name: eperisone hydrochloride) and vertigo and equilibrium disturbance treatment Merislon (generic name: betahistine mesilate) in Asia (9 countries/regions*) to a subsidiary of DKSH Holding Ltd. In our Asia and Latin America Pharmaceuticals Business (ALA Region), we are shifting to a product portfolio centered on new global products in our strategic areas of neurology and oncology. Eisai believes that this divestiture agreement will accelerate the pursuit of the best marketing mix in the ALA Region. Under the terms of the ... Read more

Japan – Eisai Announces Plans to Submit Application for Partial Change to Label for Dosage and Administration of Aricept for Treatment of Dementia with Lewy Bodies Based on Results of Drug Reexamination

Eisai Co., Ltd. announced today that it has received notification that Aricept (donepezil hydrochloride), a treatment for Alzheimer’s disease and dementia with Lewy bodies that was discovered and developed in-house, has been granted Category 2* status based on the results of a reexamination of its efficacy, dosage and administration for the treatment of dementia with Lewy bodies (DLB) in Japan. In conjunction with this, Eisai plans to promptly submit an application for a partial change to label regarding dosage and administration. The indication for DLB remains unchanged. The indication of “suppression of progression of dementia symptoms in DLB” was approved ... Read more

Eisai Satisfies All-case Study Requirement for Antiepileptic Agent Inovelon

Eisai Co., Ltd. announced today that it has received notification from Japan’s Ministry of Health, Labour, and Welfare (MHLW) that the “all-case study” specified post-marketing observational study condition required at the time of approval of antiepileptic agent Inovelon Tablets 100 mg and 200 mg (rufinamide) as an adjunctive therapy to other antiepileptic drugs (AEDs) for treatment of Lennox-Gastaut syndrome (LGS) has been cleared. In March 2013, the MHLW approved Inovelon as an adjunctive therapy with other antiepileptic drugs for tonic and atonic seizures associated with LGS showing insufficient response to other antiepileptics, with the following condition: “Because of the very ... Read more

Japan – Eisai: Metoject Subcutaneous Injection Syringe (Methotrexate) Approved in Japan for Rheumatoid Arthritis

Eisai Co., Ltd. and nippon medac Co., Ltd., a subsidiary of medac Gesellschaft fur klinische Spezialpraparate mbH announced today that they have obtained manufacturing and marketing approval from the Japanese Ministry of Health, Labour and Welfare for the indication of the anti-rheumatic agent “Metoject Subcutaneous Injection 7.5mg syringe 0.15mL, 10mg syringe 0.20mL, 12.5mg syringe 0.25mL and 15mg syringe 0.30mL” (methotrexate, “MTX”) for the treatment of rheumatoid arthritis. Metoject will be the first self-administrable MTX subcutaneous injection formulation for rheumatoid arthritis in Japan. Based on the license agreement signed by Eisai and medac GmbH in May 2019, nippon medac will hold ... Read more