These results far exceed what initial clinical trials indicated, prompting the UK government to allow the drug to be made available in the NHS on a trial basis, to enable patients unable to purchase it from the private sector to obtain it.
The study, which was presented at the Alzheimer's Clinical Trials Conference and included about 2,000 patients, compared people who received treatment at an early stage of the disease with those who did not.
The results showed that long-term treatment with licanimab – commercially known as Leqembi and produced by Eisai – can delay the progression of the disease from mild cognitive impairment to intermediate Alzheimer’s by an average of 8.3 years in patients with low levels of amyloid protein in the brain who started treatment early.
Data was also presented showing the possibility of providing an injectable version of the drug, which is less expensive and easier to use than the current version given by intravenous infusion (giving the drug directly into the bloodstream through a vein using a thin tube known as an IV or intravenous catheter), which may expand its potential use in the future.
Dr. Richard Oakley, associate director of research and innovation at the Alzheimer's Association, said the new findings were "very promising," especially as they are based on actual use of the treatment outside of clinical trials.
He added that starting treatment early may provide greater benefits, but at the same time stressed the need to understand what slowing the disease means for patients' daily lives, such as their ability to remain independent for a longer period.
David Thomas, head of policy and public affairs at Alzheimer's Research UK, stressed the importance of the new anti-amyloid drugs, explaining that they are currently only available to patients who obtain them privately because they are not approved within the NHS.
It is worth noting that another Alzheimer's drug, "donanimab," was approved in the UK, but it was also rejected for use in the NHS. (The reason for rejecting both drugs for use in the NHS is due to a cost-benefit assessment).
Likanimab and donanimab belong to a class of antibody-based therapies designed to target amyloid protein buildup in the brain, with the goal of slowing cognitive decline rather than just treating symptoms.
The National Institute for Health and Care Excellence (NICE) stated in its final draft, published in June, that the two drugs are capable of delaying the progression of mild to moderate disease for a period of four to six months, but considered that this does not justify their high cost, describing the benefit as "modest at best."
