Updated: Eli Lilly expects FDA decision on Alzheimer’s drug by end of year as it unveils full PhIII data

Eli Lil­ly said Mon­day morn­ing that it has sub­mit­ted an ap­pli­ca­tion for its ex­per­i­men­tal Alzheimer’s drug do­nanemab to the FDA, and ex­pects a de­ci­sion by the end of the year.

If full ap­proval is grant­ed, do­nanemab would be the sec­ond Alzheimer’s drug in 20 years to reach that mile­stone, fol­low­ing Bio­gen and Ei­sai’s Leqem­bi. The FDA ap­proved Leqem­bi ear­li­er in Ju­ly, open­ing the doors to cov­er­age for mil­lions of Medicare re­cip­i­ents.

To read Endpoints News become a free subscriber

Unlock this article instantly, along with access to limited free monthly articles and our suite of newsletters

SIGN UP LOG IN