Memory & Movement Charlotte Statement on Donanemab
On May 3, 2023 Eli Lilly Pharmaceutical Company published a news release heralding the positive results of its phase 3 clinical trial of donanemab for the treatment of early Alzheimer’s disease. This is the trial the FDA will use to render a decision on approval.
While the publication of the full study in a peer review journal will likely follow in the coming months, the news release included considerable details about the drug’s efficacy and safety, allowing at least a preliminary comparison to the recently approved drug lecanemab. Memory and Movement Charlotte went on record with our opinion about lecanemab a few months ago, specifically expressing concern about side effects in the setting of a very modest slowing of disease progression. Donanemab has a similar risk but appears to offer more robust slowing of disease progression. Our clinic will review the full published data once available and report back to our patients and their families.
We share your opinion that time is of the essence with Alzheimer’s disease, so we hope the FDA will make a prompt decision regarding full approval. Our clinic contacted Eli Lilly immediately upon reviewing the news release and the company is anticipating approval later this year. This medication will be expensive, but full approval based on safety and efficacy will lead to significant coverage by insurers.
Donanemab will require a monthly intravenous infusion as well as quarterly brain scans to monitor for bleeding or swelling as a side effect. However, the ratio of efficacy to safety appears favorable. As we learn more about this medication we will keep our patients and families informed. We remain hopeful that this is a true breakthrough in the treatment of Alzheimer’s disease.