BioArctic & Eisai’s MAA for Lecanemab Receives Approval from the US FDA to Treat Early Alzheimer's Disease
- The EMA has approved the MAA for lecanemab for the treatment of patients with early Alzheimer's disease whose amyloid pathology has been confirmed. BioArctic is qualified for a milestone of MEUR 5 in accordance with EMA's acceptance of the file·
- Previously, lecanemab received accelerated approval from the US FDA for the treatment of AD & Eisai also submitted an sBLA to the US FDA for approval based on the results from the P-III (Clarity AD) confirmatory study (Jan 2023). Eisai also submitted an MAA to the PMDA (Jan 2023) & a BLA submission to the NMPA was also initiated (Dec 2022)·
- Lecanemab is humanized IgG1 mAb directed against aggregated soluble & insoluble forms of amyloid-beta (Aβ) which was jointly developed by BioArctic & Eisai.
Ref: PRNewswire | Image: BioArctic
Related News:- BioArctic Partner Eisai Reports MAA Submission of Leqembi (lecanemab) to the EMA for Early Alzheimer's Disease
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