Eisai and Biogen have jointly announced the submission of a Marketing Authorization Application (MAA) for lecanemab, an investigational anti-amyloid beta (Aβ) protofibril antibody, to the Medicines and Healthcare products Regulatory Agency (MHRA).
The MAA seeks approval to treat early Alzheimer's disease, specifically mild cognitive impairment due to Alzheimer's disease (AD) and mild AD dementia, in patients with confirmed amyloid pathology in the brain. The MHRA has granted Lecanemab the designation of the Innovative Licensing and Access Pathway (ILAP).
Data from the Phase III Clarity AD study support the submission of the MAA. These studies demonstrated that lecanemab treatment resulted in a reduction of clinical decline in early Alzheimer's disease. The MAA is currently undergoing validation to determine its acceptance by the MHRA.
Lecanemab works by selectively binding and eliminating soluble, toxic Aβ aggregates (protofibrils) that are believed to contribute to the neurotoxicity associated with Alzheimer's disease. This mechanism of action holds the potential to impact disease pathology and slow down disease progression. The Clarity AD study achieved its primary and secondary endpoints with highly statistically significant results.
Eisai is leading the development and regulatory submissions for lecanemab globally, with both Eisai and Biogen collaborating on the commercialization and promotion of the product. Eisai holds the final decision-making authority in this partnership.