New results from the final stage of extensive clinical trials for the anti-amyloid immunotherapy drug “donanemab” have confirmed significant benefits for people in the early stage of Alzheimer’s disease.
The drug, which was shown to slow cognitive and functional decline by 22%, could receive regulatory approval for use in the USA by the end of the year. Applications by the manufacturer Eli Lilly to distribute donanemab in the UK and Europe are likely to follow.
Donenemab was more effective during the earliest stages of symptomatic Alzheimer’s disease and also in people with mild cognitive impairment (MCI), slowing decline by 60% in these groups. There was an overall 40% slowing in decline of everyday activities such as driving, doing hobbies and managing finances. In a significant number of cases, there was zero progression in disease symptoms over the 18 months of the trial.
If US regulatory approval is forthcoming, donanemab will join two other recently discovered monoclonal antibody drugs licensed for distribution there, lecanemab and aducanumab. But aducanumab did not win approval from the UK regulatory agency and a decision on lecanemab is not expected here until next year.
“The treatment effect is modest [for donanemab], as is the case for many first-generation drugs, and there are risks of serious side effects that need to be fully scrutinised before donanemab can be marketed and used,” said Dr Susan Kohlhaas, research director at Alzheimer’s Research UK. “However, this news underlines the urgency of preparing the NHS to make these treatments available should regulators deem them safe and effective.”
Major investment will be needed in early diagnosis, including PET scanners, if Alzheimer’s is to be treated. At present, only 2% of people would be diagnosed early enough to benefit from donanemab.