Biogen: marketing application for lecanemab in UK
(CercleFinance.com) - Eisai Co and Biogen Inc.
yesterday announced that Eisai has submitted a marketing authorisation application (MAA) to the UK Medicines and Healthcare products Regulatory Agency (MHRA) for lecanemab.
Lecanemab, an investigational anti-amyloid beta protofibrillar antibody for the treatment of early Alzheimer's disease with confirmed amyloid pathology in the brain, has been designated by the MHRA for the Innovative Licensing and Access Pathway (ILAP).
The MA is based on the results of the confirmatory Phase III Clarity AD study and the Phase IIb clinical trial, which demonstrated that treatment with lecanemab reduced the clinical decline of early Alzheimer's disease.
Eisai is responsible for the development of lecanemab and the worldwide marketing authorisation applications. Eisai and Biogen jointly market and promote the product, and Eisai has a final decision-making authority.
Copyright (c) 2023 CercleFinance.com. All rights reserved.
yesterday announced that Eisai has submitted a marketing authorisation application (MAA) to the UK Medicines and Healthcare products Regulatory Agency (MHRA) for lecanemab.
Lecanemab, an investigational anti-amyloid beta protofibrillar antibody for the treatment of early Alzheimer's disease with confirmed amyloid pathology in the brain, has been designated by the MHRA for the Innovative Licensing and Access Pathway (ILAP).
The MA is based on the results of the confirmatory Phase III Clarity AD study and the Phase IIb clinical trial, which demonstrated that treatment with lecanemab reduced the clinical decline of early Alzheimer's disease.
Eisai is responsible for the development of lecanemab and the worldwide marketing authorisation applications. Eisai and Biogen jointly market and promote the product, and Eisai has a final decision-making authority.
Copyright (c) 2023 CercleFinance.com. All rights reserved.