FDA adcomm votes unanimously in favor of full approval for Eisai’s new Alzheimer’s drug

The FDA’s Pe­riph­er­al and Cen­tral Ner­vous Sys­tem Drugs Ad­vi­so­ry Com­mit­tee on Fri­day vot­ed 6-0 in fa­vor of ful­ly ap­prov­ing Ei­sai and Bio­gen’s Alzheimer’s drug Leqem­bi (lecanemab), which first won an ac­cel­er­at­ed ap­proval in Jan­u­ary.

The full ap­proval, ex­pect­ed on or be­fore Ju­ly 6, would open the door to wider in­sur­ance and Medicare cov­er­age for those with mild cog­ni­tive im­pair­ment or mild de­men­tia and con­firmed pres­ence of amy­loid be­ta pathol­o­gy but who could not or do not want to pay the $26,500 per year list price.

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