The Scientific Advisory Group (SAG) will meet to examine the marketing authorization application (MAA) for Lecanemab, also known as LEQEMBI®, in the European Union (EU), according to a release from Eisai Co., Ltd. The SAG meeting is scheduled for March 31, 2024, which is before the fiscal year 2023 ends.
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) is the one that started the SAG assembly. Its goal is to provide unbiased advice on technical or scientific issues related to items that the CHMP is evaluating or on other scientific issues relevant to the CHMP’s duties.
Eisai anticipates that in the first quarter of the fiscal year 2024, which ends on June 30, 2024, a decision about the MAA for Lecanemab will be made by the European Commission. This conclusion relies on the CHMP’s opinion being received by March 31, 2024, after the debates undertaken by the SAG.
Lecanemab’s worldwide development and regulatory filings are led by Eisai, while the product’s co-commercialization and co-promotion are jointly carried out by Eisai and Biogen Inc. Eisai continues to have the last say over decisions.
Lecanemab is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody that targets aggregated soluble and insoluble forms of amyloid-beta (Aβ). It is the product of a strategic research cooperation between Eisai and BioArctic. LEQEMBI was given the customary approval in the United States. On July 6, 2023, the Food and Drug Administration (FDA) approved it as a disease-modifying medication for individuals with moderate cognitive impairment (MCI) or mild dementia, a particular stage of Alzheimer’s disease.
On September 25, 2023, the Ministry of Health, Labour, and Welfare (MHLW) in Japan gave Eisai permission to produce and sell LEQEMBI, which slows the progression of MCI and mild dementia brought on by AD. Furthermore, on January 5, 2024, the National Medical Products Administration (NMPA) in China approved LEQEMBI for the treatment of mild AD dementia and MCI brought on by AD.
There are outstanding applications for the approval of Lecanemab in Canada, the United Kingdom, Australia, Switzerland, South Korea, and Israel. Lecanemab is covered under the Innovative Licensing and Access Pathway (ILAP) in Great Britain, which speeds up the admission of novel medications onto the market. The application in Israel has been given priority for evaluation.
Eisai is now assessing subcutaneous dose in the Clarity AD (Study 301) open-label extension (OLE) and has started a subcutaneous bioavailability study for Lecanemab. As part of Study 201, a maintenance dosage schedule is being evaluated.
Since July 2020, the Alzheimer’s Clinical Trial Consortium, Eisai, and Biogen have collaborated to conduct the Phase 3 clinical study (AHEAD 3-45) for people with preclinical AD. The study’s objective is to assess the effectiveness of Lecanemab in people who are clinically normal but have intermediate or elevated levels of amyloid in their brains.
Lecanemab is the main anti-amyloid therapy used in the Tau NexGen clinical study for Dominantly Inherited AD (DIAD), which has been running since January 2022 and is coordinated by the Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU) and Washington University School of Medicine in St. Louis.
Together, Eisai and Biogen have been working on the combined research and marketing of therapies for AD since 2014. Together, the two businesses will commercialize and promote LEQEMBI, with Eisai spearheading the product’s worldwide development and regulatory filings. The long-term cooperation between Eisai and BioArctic, which began in 2005, is concentrated on the creation and marketing of therapies for AD. Through a deal with BioArctic in December 2007, Eisai was able to acquire worldwide rights for the research, development, production, and marketing of LEQEMBI for the treatment of AD. A deal was formed in May 2015 for the development and marketing of the antibody LEQEMBI backup.
