HQ Team
June 8, 2023: Japan’s Eisai Co and Biogen Inc., have submitted a marketing authorisation application with the South Korean health authority for leqembi, an investigational drug to treat early onset of Alzheimer’s disease.
The application was submitted to the Ministry of Food and Drug Safety in South Korean and is the first for the injectable drug in Asia outside of Japan and China.
Eisai plans additional submission of applications in other Asian nations, according to a Biogen statement.
The company has also submitted applications for approval in Europe, Canada, and the UK.
Priority review
In Japan and China, the applications have been designated for priority review, and in the UK, lecanemab (branded as leqembi in the US) has been designated for the Innovative Licensing and Access Pathway (ILAP), which aims to reduce the time to market for innovative medicines.
The medicine, to treat early Alzheimer’s disease cognitive impairment and mild dementia with amyloid pathology in the brain, has shown a clinical decline in early stage of the disease during phase IIb trials, according to the statement.
Amyloidosis is a heterogeneous acquired or hereditary disease which can be localised or systemic with amyloid accumulation in the spleen, liver, kidney, blood vessels and nerves.
The study of lecanemab met its primary endpoint and all key secondary endpoints with “highly statistically significant results.”
FDA’s final nod
Eisai serves as the lead on lecanemab development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai has final decision-making authority.
The USFDA’s external advisers are slated to discuss the companies’ application for full approval of leqembi medicine on June 9, 2023.
The FDA granted accelerated approval for leqembi in January, 2023, based on phase II data which demonstrated that LEQEMBI reduced the accumulation of Aβ plaque in the brain, a defining feature of AD.
The US drug regulator stated that continued approval may be contingent upon verification of clinical benefit in a confirmatory trial.
Eisai submitted a supplemental Biologics License Application (sBLA) to the FDA for approval under the traditional pathway in January, 2023.
Phase III trials
Since July 2020 the phase 3 clinical study of individuals with pre-clinical Alzheimer’s — patients who are clinically normal and have intermediate or elevated levels of amyloid in their brains — is ongoing.
Eisai and Sweden’s BioArctic have had a long-term collaboration regarding the development and commercialization of Alzheimer’s treatment.
Eisai obtained the global rights to study, develop, manufacture and market lecanemab for the treatment of Alzheimer’s after an agreement with BioArctic in December 2007.
The development and commercialization agreement on the antibody lecanemab back-up was signed in May 2015.
