Treatment involves early Alzheimer’s disease and will be potentially used across Great Britain.
Eisai has submitted a Marketing Authorisation Application (MAA) for its lecanemab therapy – an investigational anti-amyloid beta (A?) protofibril antibody.
The drug treats early Alzheimer’s disease (AD) and specifically targets mild cognitive impairment and mild dementia with confirmed amyloid pathology in the brain.
The critical application has been submitted to the Medicines and Healthcare Products Regulatory Agency (MHRA) across Great Britain, while the treatment has been assigned by the MHRA for the Innovative Licensing and Access Pathway (ILAP).
The MAA follows results from phase 2b research, in addition to the pivotal phase 3 Clarity study, which showed that lecanemab reduced clinical decline in early AD when compared to the placebo after 18 months.
Lecanemab selectively binds and eliminates soluble, toxic A? aggregates that contribute to the neurotoxicity in AD. The Clarity AD study met all its primary endpoints and, indeed, all key secondary endpoints with statistically significant results.
Nick Burgin, chief operating officer and president of global value and access at Eisai EMEA, was encouraged by the application: “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.”
He added: “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 the development and regulatory submissions globally for lecanemab, with both Eisai and Biogen co-commercialising and co-promoting the treatment.
The application is subject to validation to establish whether it will be accepted by the MHRA.