DATA GRAPHICS | Data Byte
Eleven label expansions also among committee’s November recommendations
By Selina Koch, Executive Editor, and Gunjan Ohri, Data Content Analyst
November 16, 2024 1:41 AM UTC
In a reexamination, EMA’s CHMP concluded that the benefit-risk profile of Alzheimer’s disease therapy Leqembi is positive if certain high-risk patients are excluded from treatment.
The committee had initially recommended against approval of β-amyloid mAb Leqembi lecanemab from Eisai Co. Ltd. (Tokyo:4523) and Biogen Inc. (NASDAQ:BIIB), citing modest benefit in the context of serious safety concerns. With much of the drug’s risk of brain swelling and bleeding concentrated in patients who carry two copies of the risk allele APOE4, CHMP now recommends approval of Leqembi but only patients who carry zero or one APOE4 allele…
- SEO Powered Content & PR Distribution. Get Amplified Today.
- PlatoData.Network Vertical Generative Ai. Empower Yourself. Access Here.
- PlatoAiStream. Web3 Intelligence. Knowledge Amplified. Access Here.
- PlatoESG. Carbon, CleanTech, Energy, Environment, Solar, Waste Management. Access Here.
- PlatoHealth. Biotech and Clinical Trials Intelligence. Access Here.
- Source: https://www.biocentury.com/article/654219/ema-s-chmp-finds-path-to-leqembi-nod-backs-three-other-new-drugs