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News Release
“LEQEMBI?” (Lecanemab) Approved for the Treatment of Alzheimer’s Disease in the United Arab Emirates
Eisai and Biogen announced today that the Ministry of Health and Prevention in the United Arab Emirates (UAE) has approved humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody “LEQEMBI?” (lecanemab) for the treatment of Alzheimer’s disease (AD).
Update Regarding the Regulatory Status of LEQEMBI? Subcutaneous Formulation
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) reconfirmed today that the regulatory
status for anti-amyloid beta (Aβ) protofibril antibody LEQEMBI? (generic name: lecanemab) subcutaneous
(SC) autoinjector, explained at the Financial Disclosure Meeting on August 2, 2024, is as follows.
EISAI ENTERS INTO LICENSE AGREEMENT FOR FOSRAVUCONAZOLE IN ASIA/OCEANIA WITH SATO PHARMA
Eisai Co., Ltd. announced today that the company has entered into a license agreement regarding the development and commercialization rights for the antifungal agent fosravuconazole in the Asia/Oceania region with Sato Pharmaceutical Co., Ltd.
“LEQEMBI?” (Lecanemab) Approved for the Treatment of Alzheimer’s Disease in South Korea
Eisai and Biogen announced today that the Ministry of Food and Drug Safety
(MFDS) in South Korea has approved humanized anti-soluble aggregated amyloid-beta (Aβ)
monoclonal antibody “LEQEMBI?” (lecanemab) for treatment in adult patients with mild cognitive
impairment due to Alzheimer’s disease (AD) or mild AD (early AD).
Eisai Initiates Rolling Biologics License Application to US FDA for LEQEMBI? (lecanemabirmb) for Subcutaneous Maintenance Dosing for the Treatment of Early Alzheimer’s Disease Under the Fast Track Status
Eisai and Biogen announced today that Eisai has initiated the rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for lecanemab-irmb (U.S. brand name: LEQEMBI?) subcutaneous autoinjector for weekly maintenance dosing after it was granted Fast Track designation by the FDA.
