BIIB, Eisai's Leqembi Approved in Other Countries Leqembi gained full approval from the FDA for early AD in the United States s in July 2023. The drug is also approved in China, Japan, Great ...

European regulators have finally approved the Alzheimer’s treatment Leqembi after an advisory committee initially rejected the drug last summer and then reconsidered it. The infused treatment ...

Eisai and Biogen can finally put their European regulatory uncertainty surrounding Alzheimer's disease medicine Leqembi behind them and focus on the drug's launch in the region. After months of ...

Burdened by competitive pressures for its stalwart multiple sclerosis franchise, Biogen has weathered years of sales declines ...

Eisai Co., Ltd. and Biogen Inc. announced that the European Commission has granted marketing authorization for lecanemab, marketed as Leqembi®, making it the first therapy in the EU to target an ...

Last accessed: April 2025. Reuters. 2023. Japan approves Alzheimer's treatment Leqembi by Eisai and Biogen. Last accessed: April 2025. The Pharma Letter. 2024. Brief - Alzheimer drug Leqembi now ...

In addition, Eisai must conduct a post-authorization safety study, including setting up a patient registry for the European Union. Now each European country must set its own rules for access and ...

UK regulators are set to review a proposed label update for Eisai (TYO: 4523) and Biogen’s (Nasdaq: BIIB) Alzheimer’s drug ...

Eisai must offer trainings on how to detect and manage ARIA ... and quite unrealistic that patients in the EU would have been left in the cold by not having access to Leqembi,” he wrote to Alzforum.

President Donald Trumpsaid on Sunday that his top priority was to secure a fair trade deal with China, after the fallout from his chaotic tariff policy shook consumer and business sentiment ...