Donanemab Approved in US for Early Alzheimer's Treatment, UK Approval Uncertain
Key Insights
The FDA approved donanemab in July 2024 for early symptomatic Alzheimer's (search), including mild cognitive impairment and mild dementia.
Clinical trials showed donanemab slowed cognitive decline by approximately 22% compared to placebo over 18 months.
UK approval is uncertain, with NICE potentially rejecting it due to high costs relative to modest benefits, following a similar decision on lecanemab.
Donanemab, a new Alzheimer's (search) treatment developed by Eli Lilly, has been approved for use in the United States for individuals with early symptomatic Alzheimer's disease (search), including those with mild cognitive impairment and mild dementia. The FDA's approval in July 2024 was based on clinical trial data demonstrating a significant slowing of cognitive decline. However, its future availability in the UK remains uncertain.
Clinical Trial Results
The approval of donanemab was supported by an 18-month study. Results indicated that patients receiving donanemab experienced approximately 22% less decline in memory and cognitive function compared to those receiving a placebo infusion. This outcome suggests a potential clinical benefit for patients in the early stages of Alzheimer's disease (search).
UK Approval Hurdles
Despite the FDA's approval, insiders suggest that the National Institute for Health and Care Excellence (NICE) in the UK is likely to reject the use of donanemab within the National Health Service (NHS). This potential rejection follows a similar decision regarding another Alzheimer's (search) drug, lecanemab, where NICE cited that the high costs did not justify the limited clinical benefits.
Sources indicate that donanemab's administration costs, estimated between £50,000 and £100,000 per year, could be a significant barrier to its approval. The UK government had previously pledged to expedite the approval of medicines already approved by trusted regulators in the US, Europe, and Japan. However, months after the FDA's approval, a decision regarding donanemab's use in the UK is still pending.
Cost-Benefit Concerns
The primary concern revolves around the cost-effectiveness of donanemab. NICE's previous rejection of lecanemab set a precedent, and the expectation is that donanemab, with its similar but potentially higher cost profile, will face the same outcome. The decision hinges on whether the clinical benefits observed in trials sufficiently outweigh the substantial financial investment required for its widespread use within the NHS.