FDA grants full approval to Leqembi, opening up coverage of Alzheimer’s drug by Medicare

For the first time in 20 years, the FDA has be­stowed full ap­proval on a drug to treat Alzheimer’s dis­ease, open­ing the door to cov­er­age for mil­lions of Medicare re­cip­i­ents.

While Ei­sai and Bio­gen’s drug Leqem­bi had been avail­able since Jan­u­ary af­ter the FDA cleared it through the ac­cel­er­at­ed ap­proval path­way, the lack of re­im­burse­ment from Medicare had been a ma­jor bar­ri­er for its up­take.

“To­day is a tri­umph for the Alzheimer’s dis­ease com­mu­ni­ty af­ter so many years of hard work by sci­en­tists, clin­i­cians, and clin­i­cal tri­al par­tic­i­pants,” Ei­sai’s US chair­man and CEO Ivan Che­ung told End­points News in an in­ter­view. “This is a very hum­bling mo­ment. I per­son­al­ly wish this would have come many years ear­li­er.”

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