À´Àû¹ú¼Êw66¹Ù·½ÍøÕ¾ÔÚÓ¢¹úÌá½»LecanemabÉÏÊÐÐí¿ÉÉêÇë

5ÔÂ22ÈÕ £¬À´Àû¹ú¼Êw66¹Ù·½ÍøÕ¾ÒÑÏòÓ¢¹úÒ½Ò©ºÍ½¡¿µ²úÎï¹ÜÀí¾Ö£¨MHRA£©Ìá½»ÁËLecanemabµÄÉÏÊÐÐí¿ÉÉêÇ루MAA£©¡£LecanemabÊÇÒ»ÖÖʵÑéÐÔ¿¹µí·ÛÑùÂѰצ£¨A¦Â£©Ô­ÏËά¿¹Ìå £¬ÓÃÓÚÖÎÁÆ´óÄÔÖÐÈ·ÈÏ´æÔÚµí·ÛÑùÂѰײ¡ÀíµÄÔçÆÚ°¢¶û´Äº£Ä¬²¡£¨AD£©ºÍÇá¶ÈADÒýÆðµÄÈÏÖªÕÏ°­¡£LecanemabÒѱ»MHRAÖ¸¶¨ÎªILAP*¡£

»ùÓÚÑéÖ¤ÐÔIIIÆÚClarity ADÑо¿ºÍIIbÆÚÁÙ´²Ñо¿£¨study 201£©µÄ½á¹ûÌá½»MAAÉêÇë¡£¸Ã½á¹û±íÃ÷ £¬Í¨¹ýLecanemabÖÎÁÆ¿ÉÒÔ¼õÉÙÔçÆÚADµÄÁÙ´²Ë¥ÍË £¬µ«MHRAÊÇ·ñ½ÓÊÜÕâЩÑо¿½á¹û £¬ÔòÐèÒª½øÒ»²½µÄÑéÖ¤¡£Clarity ADÑо¿µ½´ïÁËÖ÷ÒªÖÕµãºÍËùÓÐÒªº¦´ÎÒªÖյ㠣¬½á¹û¾ßÓÐÏÔÖøͳ¼ÆѧÒâÒå¡£LecanemabÑ¡ÔñÐԵؽáºÏ²¢Ïû³ý¿ÉÈÜÇÒÓж¾µÄA¦Â¾Û¼¯Ì壨ԭÏËά£© £¬ÓÐÖúÓÚ¼õ»ºADµÄÉñ¾­¶¾ÐÔ¡£Òò´Ë £¬Lecanemab¿ÉÄܶԼ²²¡²¡ÀíºÍ¼²²¡½ø³ÌÓÐDZÔÚµÄÓ°Ïì¡£

LecanemabµÄÈ«Çò¿ª·¢ºÍ×¢²áÉêÇëÓÉÀ´Àû¹ú¼Êw66¹Ù·½ÍøÕ¾Ö÷µ¼ £¬¶ø²úÎïÔòÓÉÀ´Àû¹ú¼Êw66¹Ù·½ÍøÕ¾ºÍ²³½¡ÅäºÏ½øÐÐÉÌÒµ»¯ºÍÍƹã¡£À´Àû¹ú¼Êw66¹Ù·½ÍøÕ¾ÓµÓÐ×îÖÕ¾ö²ßȨ¡£

 

*ILAPÊÇÓ¢¹úMHRAΪÐÂÏîÄ¿¿ª·¢ÌṩµÄÒ»¸ö;¾¶ £¬ÆäÄ¿±êÊÇËõ¶Ì´´ÐÂÒ©ÎïÉÏÊÐʱ¼ä £¬ÒÔÖÎÁÆΣ¼°ÉúÃü¡¢ÑÏÖØË¥ÈõµÄ¼²²¡ºÍ/»ò»¼ÕßÐèÇóÏÔÖøδµÃµ½Âú×ãµÄ¼²²¡¡£ILAPÖ¼ÔÚͨ¹ý¼ÓÇ¿ÉêÇëÕß¡¢MHRAºÍ±¨Ïú»ú¹¹£¨NICE£©Ö®¼äµÄЭµ÷À´ÊµÏÖÕâһĿ±ê £¬ÎªÉÏÊÐÐí¿ÉÉêÇ루MAA£©µÄÌá½»×öºÃ×¼±¸ £¬ÒÔÖ§³Ö¼ÓËÙ×¼Èë¡£