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
Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at firstname.lastname@example.org.