Eisai has submitted a marketing authorisation application (MAA) for lecanemab, an investigational anti-amyloid beta (Aβ) protofibril antibody to the Medicines and Healthcare products Regulatory Agency (MHRA) in Great Britain.
The MAA is for the treatment of early Alzheimer’s disease (AD) (mild cognitive impairment due to AD and mild AD dementia) with confirmed amyloid pathology in the brain.
The investigational therapy has been designated by the MHRA for the Innovative Licensing and Access Pathway (ILAP).
The submission is based on the results of the Phase IIb clinical study (Study 201) and Phase III Clarity AD study, which demonstrated that lecanemab treatment showed a reduction of clinical decline in early AD vs. placebo at 18 months. The MAA is subject to a validation to determine whether it will be accepted by the MHRA.
Lecanemab selectively binds and eliminates soluble, toxic Aβ aggregates (protofibrils) that are thought to contribute to the neurotoxicity in AD. The Clarity AD study met its primary endpoint and all key secondary endpoints with statistically significant results.
“Submission of our MAA to the MHRA brings us one step closer to bringing a much-needed treatment to an area of significant unmet need,” said Nick Burgin, Chief Operating Officer and President of Global Value and Access, Eisai EMEA. “This important milestone follows decades of research and reflects our commitment to alleviate the burden of AD for patients, and their families and carers. We look forward to working with the MHRA over the coming months to support the review of our clinical evidence.”
Eisai leads lecanemab development and regulatory submissions globally, with both Eisai and Biogen co-commercialising and co-promoting the product and Eisai having final decision-making authority.
