Alzheimer's "milestone drug" to be launched soon? Eli Lilly announces submission to FDA for review, expected conclusion by the end of the year.

Pharmaceutical giant Eli Lilly announced the complete report of a milestone new drug for Alzheimer's disease and submitted it to FDA for review, potentially leading to a showdown with Biogen later this year.

On Monday local time, Eli Lilly unveiled the full results of the Phase 3 clinical trial of donanemab, its investigational antibody, at the Alzheimer's Association International Conference held in Amsterdam. The results showed that in the early stages of Alzheimer's disease, the antibody can slow down the decline in patients' cognitive function by 35%.

Eli Lilly has published the trial results in the Journal of the American Medical Association (JAMA).

A total of 1,736 participants with mild to moderate Alzheimer's disease were recruited for the donanemab trial, with an average age of 73. They were randomly assigned in a 1:1 ratio to the treatment group and the control group, with half receiving intravenous infusion therapy and half receiving a placebo every 4 weeks for a duration of 18 months.

The latest complete report states that in individuals with mild cognitive impairment (MCI), the integrated Alzheimer's Disease Rating Scale (iADRS), which assesses cognitive and functional abilities, showed a 60% reduction in clinical decline, and the Clinical Dementia Rating-Sum of Boxes (CDR-SB) score indicated a 46% reduction in the rate of cognitive decline.

Anne White, Executive Vice President and President of Lilly Neuroscience, emphasized that these findings underscore the importance of "early detection and diagnosis" in altering the course of the disease.

On Monday, Eli Lilly also announced that it has submitted an application for donanemab to the U.S. Food and Drug Administration (FDA), with a decision expected by the end of the year.

In addition, Eli Lilly's competitor, Biogen, and Eisai, a Japanese pharmaceutical company, have already received full approval from the FDA this month for another Alzheimer's antibody drug called lecanemab. If donanemab successfully obtains FDA approval, the two heavyweight drugs may go head-to-head later this year.

Experts in Alzheimer's disease believe that donanemab and lecanemab could be milestones in the treatment of dementia.

Richard Oakley, Deputy Head of Research at the Alzheimer's Society in the UK, stated:

The last eight months have been a real turning point, with decades of research yielding no positive results, and now we have two drugs that have been shown to slow the progression of Alzheimer's.

Oakley also mentioned that although direct comparison is difficult due to differences in the clinical trial designs of the two drugs, preliminary evidence suggests that donanemab may be more effective for early-stage Alzheimer's patients compared to lecanemab.

Howard Fillit, Chief Science Officer of the Alzheimer's Drug Discovery Foundation in the United States, stated that another potential advantage of donanemab is that patients receive injections every two weeks, while lecanemab requires injections twice as often.

Leqembi is priced at $26,500 per year in the United States, and Lilly has stated that it is not yet ready to set a price for its medication. Research firm Datamonitor Healthcare predicts that by 2030, the combined annual sales of the two products in major global markets will reach $9 billion.