FDA Postmarket Requirements For Leqembi Leave Out CMS Registry

A former CMS official said FDA’s advice that drug maker Eisai participate in a private registry rather than the one established by CMS for post-market studies it must conduct on its newly approved Alzheimer’s drug means FDA likely does not believe CMS’ data will be adequate to determine safety risks. FDA will require the primary sponsor of Leqembi (lecanemab) to conduct three postmarket studies of the treatment’s safety in at-risk patient populations, according to a notice the agency sent to...