Lil­ly gets June ad­comm for Alzheimer's drug do­nanemab, fol­low­ing ear­li­er de­lay

Eli Lil­ly will face ques­tions from a pan­el of Alzheimer’s ex­perts on June 10, set­ting up an ap­proval de­ci­sion for do­nanemab af­ter a sur­prise de­lay by the FDA in ear­ly March.

The drug will go be­fore the FDA’s Pe­riph­er­al and Cen­tral Ner­vous Sys­tem Drugs Ad­vi­so­ry Com­mit­tee, the com­pa­ny said in a state­ment Tues­day. Lil­ly has pre­vi­ous­ly said that the FDA is es­pe­cial­ly in­ter­est­ed in do­nanemab’s safe­ty, the com­pa­ny’s pro­pos­al to stop treat­ment once the drug clears up amy­loid plaques, and analy­ses that sug­gest lev­els of the brain pro­tein tau can pre­dict how well a per­son re­sponds to treat­ment.

Endpoints News

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.