認知症新薬、承認に否定的見解　エーザイ「レカネマブ」の副作用懸念―ＥＵ

　【ブリュッセル時事】欧州連合（ＥＵ）の欧州医薬品庁（ＥＭＡ）は２６日、日本の製薬大手エーザイと米医薬品大手バイオジェンが共同開発したアルツハイマー病治療薬「レカネマブ」について、医薬品を評価する委員会が販売を承認しないよう勧告したと発表した。症状の進行を遅らせる効果が、脳出血といった副作用のリスクに見合っていないと指摘した。
　エーザイは声明で「極めて残念だ」と表明し、委員会に再審議を求める方針を示した。同社は２０２３年１月、ＥＭＡに販売承認を申請した。（2024/07/27-05:14）

The European Medicines Agency has said that its committee for assessing medicines recommended "not granting a marketing authorization" to Alzheimer's drug lecanemab.
   According to the announcement by the EMA, which is under the European Union, on Friday, the committee pointed out that the effect of lecanemab, developed jointly by Japan's Eisai Co. and U.S. drugmaker Biogen Inc., in delaying cognitive decline "does not counterbalance" the risk of serious side events, such as bleeding in the brain.
   "We are extremely disappointed" by the EMA committee's negative opinion and "understand that this may also be disappointing for the wider Alzheimer's disease community," Eisai said in a statement, adding that the company will seek re-examination by the committee.
   Eisai applied for sales approval of the drug to the EMA in January 2023.
   Lecanemab was developed to treat patients in early stages of Alzheimer's disease. Clinical trials confirmed that patients given lecanemab saw the progress in their symptoms slow by 27 pct compared with those who did not take the medicine.