In surprise move, FDA delays decision on Lilly’s Alzheimer’s drug, will convene advisory committee

The FDA has pushed back its de­ci­sion on Eli Lil­ly’s high­ly an­tic­i­pat­ed Alzheimer’s drug do­nanemab and plans to con­vene an ad­vi­so­ry com­mit­tee to re­view it, a sur­prise de­lay for a treat­ment that many ex­perts thought would be ap­proved with rel­a­tive ease.

Ac­cord­ing to a Lil­ly press re­lease an­nounc­ing the de­lay, the agency has ad­di­tion­al ques­tions about do­nanemab’s safe­ty, the clin­i­cal tri­al de­sign, the de­ci­sion to take pa­tients off the drug once it clears amy­loid plaques from the brain, and Lil­ly’s strat­i­fi­ca­tion of pa­tients based on how much tau pro­tein is in their brain — where high­er lev­els in­di­cate a more ad­vanced dis­ease.

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