European Medicines Agency
In Brief This Week: BMS, AstraZeneca, Daiichi Sankyo, Opus Genetics, Mindera Health
News items for the week of Aug. 19, 2024.
EMA's CHMP Recommends Against Approval for Eisai, Biogen's Alzheimer's Drug Leqembi in Europe
The committee said the drug's modest clinical benefit doesn't outweigh its significant safety risks, but Eisai will ask the CHMP to reexamine its opinion.
Pfizer's Hemophilia B Gene Therapy Nabs Conditional Marketing Authorization in Europe
The one-time gene therapy, marketed as Durveqtix in Europe, will be available in all 27 EU member states, Iceland, Liechtenstein, and Norway.
EMA's CHMP Issues Positive Opinion on Pfizer's Hemophilia B Gene Therapy
The gene therapy, which delivers a variant of the FIX gene, has already been approved in the US and Canada.
Biogen's Qalsody Approved as Treatment for Genetic Form of ALS in European Union
The drug for patients with ALS caused by mutations in the SOD1 gene has been granted marketing authorization under exceptional circumstances.