EU Rejects Eisai and Biogen's Leqembi Treatment

The European Medicines Agency (EMA) has rejected Eisai and Biogen's Alzheimer's treatment, Leqembi (lecanemab), citing that the risks associated with the drug, particularly severe brain swelling, outweigh its modest benefits in slowing cognitive decline. This decision follows the drug's approval in several other countries, including the U.S., where it has faced a sluggish rollout due to diagnostic and logistical challenges. The EMA emphasized the limited improvement in cognitive functions and highlighted the risk of amyloid-related imaging abnormalities (ARIA) in patients, especially those with the APOE4 gene variant. Both companies expressed disappointment and plan to seek re-examination of the decision. Meanwhile, Leqembi's recent launch in China offers a new treatment option amidst rising Alzheimer's cases, expected to grow significantly by 2050. With the ongoing challenges in Europe, Leqembi remains a critical focus for Biogen and Eisai's business recovery efforts.