Kisunla (donanemab) gains full FDA approval

Lilly’s Alzheimer’s drug is a challenger for Biogen and Eisai’s Leqembi

July 2, 2024: Eli Lilly’s anti-amyloid therapy donanemab for Alzheimer’s disease was rejected for accelerated approval last year, but the FDA has now given it full approval. The FDA has cleared donanemab-abzt, branded as Kisunla, to treat adults with early symptomatic Alzheimer’s disease, including people with mild cognitive impairment and those in the mild dementia stage of AD.

Kisunla’s indication is almost identical to the FDA-approved use for Leqembi. Both drugs need confirmation of amyloid beta pathology in patients’ brain tissue before treatment can start, and both carry a warning on the risk of amyloid-related imaging abnormalities (ARIA), which are known side effects of these antibodies that target the toxic aggregates of beta amyloid proteins.

However, Eli Lilly highlighted one advantage of Kisunla, which is that it’s the first anti-amyloid drug that allows for stopping therapy when amyloid plaques are removed – enabling fewer infusions and lower treatment costs. In addition, Kisunla is dosed every four weeks, whereas Leqembi is given as an intravenous infusion once every two weeks.

One disadvantage of Kisunla is that it is perceived to have a less favourable safety profile on ARIAs, compared with Leqembi. Leqembi’s label requires four brain MRI scans before infusions, whereas Kisunla’s requires five. The need for the extra MRI scan came after Lilly showed that an MRI prior to the second infusion led to a 25% reduction in serious ARIA cases.

Analysts have suggested that the launch of another Alzheimer’s treatment should increase the uptake of the entire class of drugs (including Leqembi and Aduhelm), due to the creation of infrastructure to support their use.

Results from the Phase 3 TRAILBLAZER-ALZ 2 trial were shared at the 2023 Alzheimer’s Association International Conference (AAIC) as a featured symposium and simultaneously published in the Journal of the American Medical Association (JAMA).

Fiona Carragher, Director of Research and Influencing at Alzheimer’s Society in the UK responded to the news:

“Donanemab is now the third drug aiming to slow down Alzheimer’s disease to be approved in the US, marking another step forward in the fight against dementia, the biggest health and social care challenge of our time. We’re proud that Alzheimer’s Society funded research over thirty years ago which identified amyloid as important in the development of Alzheimer’s disease and has led to this moment today.  

“People affected by Alzheimer’s disease in the UK will wonder what this means for them – particularly as regulators did not approve aducanumab which was also approved in the US a few years ago. There are still many hurdles before donanemab could be available on the NHS. We now need to wait for the UK regulatory authority MHRA to conduct its review of the donanemab data, and for NICE to evaluate its cost-effectiveness.  

“This drug is only suitable for people in the early stages of Alzheimer’s disease, and until we fix dementia diagnosis in the UK, only small numbers of people will get the early, accurate diagnosis needed to access the treatment if it’s approved here. Right now, a third of people with dementia in the UK do not receive a diagnosis at all, so we need to see urgent investment into the specialist workforce and equipment needed to diagnose as many people as possible.

“Donanemab is just one of nearly 130 potential treatments for Alzheimer’s disease being tested in trials, so it’s paramount we ramp up preparation for their arrival and roll-out. Alzheimer’s Society is urgently calling on the NHS to publish plans for how they intend to improve early diagnosis and deliver new treatments to the people who desperately need them.” 

Alzheimer’s Society is urgently calling on the NHS to publish plans for how they intend to improve early diagnosis and deliver new treatments to the people who desperately need them.

Fiona Carragher, Director of Research and Influencing, Alzheimer’s Society

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