US Regulator Approves Second Alzheimer’s Drug, Donanemab
The US Food and Drug Administration (FDA) has approved the Alzheimer’s drug donanemab (known commercially as Kisunla) for people in the US with confirmed amyloid positivity and a diagnosis of mild cognitive impairment (MCI) or early-stage Alzheimer’s disease.
The ruling comes after the FDA’s advisory panel voted unanimously in June that the drug shows “clinical benefit” for the treatment of the disease.
Donanemab is not the first drug approved to treat and slow the progression of early Alzheimer’s. Eisai’s lecanemab, sold as Leqembi, is already being used. Eli Lilly says donanemab will be available within weeks following the approval.
With Great Britain’s regulator also scrutinising data on the drug, the US ruling is a reminder that “there is still some way to go before donanemab might reach patients in Great Britain” said Alzheimer’s Research UK’s Executive Director, Samantha Benham-Hermetz.
Nonetheless, this decision marks “another important milestone in the global effort to tackle dementia” she continued. A decision in Great Britain is expected later this year.
Donanemab is an antibody-based treatment designed to remove amyloid, one of the hallmark proteins that builds up in the brains of people with Alzheimer’s. The drug is given as an infusion into a person’s arm every four weeks.
The FDA’s decision was based on Eli Lilly’s TRAILBLAZER ALZ-2 phase 3 clinical trials results, which were made public in July 2023.
The FDA review concluded that the drug’s 35% slowing of cognitive decline verified a “clinical benefit” to patients, with some participants in the trial able to continue to perform day-to-day activities including shopping, housekeeping, managing finances and taking medication.
Welcoming the announcement, Dr Joanne Pike, CEO of the US-based Alzheimer’s Association said
“today’s approval allows people more options and greater opportunity to have more time.”
Unlike lecanemab, donanemab use can be stopped after amyloid plaque is removed to minimal levels, which Lilly said can result in lower treatment costs and fewer infusions.
However, donanemab can cause serious side effects for some. As a consequence, the FDA’s prescribing information includes a warning for clinicians to monitor for side-effects known as amyloid-related imaging abnormalities (ARIA) which can be seen on MRI scans. These abnormalities were seen in around a quarter of participants in Eli Lilly’s trial of donanemab.
Progress for people with Alzheimer’s disease is long overdue, and although drugs like donanemab are a promising start, “we need to go further” said Benham-Hermetz.
As the news comes just 48 hours ahead of the election polls opening in the UK, Benham-Hermetz urged the next government to push forward the work of the Dame Barbara Windsor Dementia Mission. This, Benham-Hermetz said, will not only help ensure the health system is ready to lead the adoption of innovative new Alzheimer’s drugs, but also “accelerate research that will bring us closer to a cure for all forms of dementia.”
