Source – Bloomberg
Section 1: FDA Review of Donanemab Application
The U.S. Food and Drug Administration (FDA) is set to scrutinize clinical trial data concerning Eli Lilly’s groundbreaking anti-amyloid therapy, donanemab. As per a recent press release from the pharmaceutical company, an FDA advisory committee meeting is scheduled for June 10 to delve into the efficacy and safety profile of the experimental drug.
Lilly has submitted an application seeking FDA approval for donanemab’s use in treating early-stage Alzheimer’s disease. This move follows an announcement by Lilly in March regarding the FDA’s decision to convene its Central Nervous System Drugs Advisory Committee. The unexpected meeting has caused a delay in the review process, which was initially anticipated to conclude before the onset of 2024.
Section 2: Clinical Trial Insights and Side Effects
The crux of Lilly’s application rests on data primarily derived from the Phase 3 clinical trial known as TRAILBLAZER-ALZ 2 (NCT04437511). This trial involved over 1,100 participants with early-stage Alzheimer’s, who were administered either donanemab or a placebo. Encouragingly, findings after 18 months of treatment indicated that patients on donanemab exhibited significantly slower cognitive decline compared to those on the placebo.
However, the efficacy of donanemab appeared more pronounced in younger patients with milder cognitive impairments at the trial’s outset. Notably, the most prevalent side effects associated with donanemab use were amyloid-related imaging abnormalities (ARIA), characterized by brain swelling and/or bleeding. While most cases were non-serious, a small percentage of patients experienced severe ARIA, with a few cases resulting in fatalities.
Section 3: Future Prospects and Ongoing Trials
The upcoming advisory committee meeting will involve a thorough review of the trial data by a panel of experts. While specifics regarding the discussion topics remain undisclosed, Lilly has confirmed that the public portion of the hearing will be conducted virtually.
Meanwhile, Lilly is concurrently conducting another Phase 3 trial, TRAILBLAZER-ALZ 3 (NCT05026866), aimed at investigating whether donanemab could potentially prevent the onset of Alzheimer’s. This trial targets individuals with preclinical Alzheimer’s, who display normal cognitive function but exhibit abnormal accumulations of Alzheimer’s-related proteins in the brain.
Participants in TRAILBLAZER-ALZ 3 will be randomly assigned to receive either donanemab infusions or a placebo over a four-year period, with the primary objective being to assess cognitive deterioration rates. With over 200 sites across the U.S., Puerto Rico, and Japan actively enrolling participants, this trial marks a pivotal step forward in the quest to combat Alzheimer’s disease.
