Press release | 5th Jul 2024

Remaining barriers to Alzheimer’s therapeutics following Kisunla’s approval

On 2nd July 2024, the FDA approved the use of Kisunla (donanemab), Eli Lilly’s anti-amyloid antibody, for the treatment of Alzheimer’s disease patients with mild cognitive impairment and mild Dementia. This decision was based on results of the Phase 3 TRAILBLAZER-ALZ 2 trial, which demonstrated a 35% slowing of cognitive and functional decline compared to placebo at 18-months.

This makes Kisunla the second therapeutic option approved for Alzheimer’s Disease patients, following the approval of Eisai’s Leqembi (lecanemab), the first anti-amyloid, which was awarded accelerated approval in January 2023 and full approval in July 2023.

For a disease that was viewed ten years ago as being too complex and likely untreatable, these two drug approvals within a 12-month period offer patients and caregivers a new vested hope that Alzheimer’s one day may be a manageable disease.

However, despite this latest approval and significant advancements across the Alzheimer’s field significant barriers remain which limit the availability of these drugs to patients.

Access to diagnostics

Historically, diagnosis has been one of the most significant barriers for Alzheimer’s. This is due to the disease pathology starting ~20 years before any clinical symptoms appear, by which time the disease has advanced too far for . The diagnosis of Alzheimer’s currently is dependent on cognitive assessments and confirmatory clinical testing, including CSF-based tests and PET imaging (amyloid and PET), both of which require specialized clinicians to perform.

Both Leqembi and Kisunla efficacy is also linked to earlier diagnosis, as the patients that benefited the most from these therapies in clinical trials were patients at earlier stages of the disease, highlighting the importance of having a system in place which allows for quick and easy patient diagnosis. However, in many US community settings, and across the UK and EU, access to diagnostics remains challenging.

Nonetheless, some of the barriers with diagnostics are slowly being addressed, with novel blood-based biomarkers seeing significantly growing interest. These assays, whilst largely developed as in-house research-use only assays, are now being commercially developed, with several pursuing regulatory approval including Roche’s pTau217 assay. Regulatory approval is expected to increase accessibility and coverage for these diagnostics tools, hopefully improving rate of early diagnosis.

Access to Alzheimer’s drugs

Leqembi and Kisunla are dosed through intravenous infusions, requiring patients to attend a transfusion center either bi-weekly or monthly respectively. If a patient’s access to a centre is limited, this results in either a lack of treatment or a significant personal cost to attend dosing sessions.

One advancement which seeks to address this is the subcutaneous formulation of Leqembi and other novel subcutaneous developments currently in the pipeline. Patients are expected to have access to subcutaneous Leqembi as early as January 2025 in the US.

Lack of full drug coverage

Whilst Leqembi is approved in the US, it is not cheap (~$26,000 per year) and only . Similarly, Kisunla will cost between $12,522 and $32,000 for a 6-month or 12-month treatment, is not yet clear though what percentage will be covered and the out-of-pocket costs. If out-of-pocket expenses for Kisunla are similar to those of Leqembi, it is expected that many patients will not take the drug due to the financial burden it places on them.

Health disparities

Data from Kisunla’s clinical trials was generated by a study population of ~90% white individuals, with a similar demographic seen in Leqembi’s clinical trials. This narrow representation results in a significant lack of data within the Latino and African-American populations, most likely hindering any potential uptake. Ongoing studies are looking to address this issue with new clinical trials aiming to increase inclusivity and represent wider populations.

 

Long-term efficacy and durability of effect, in addition to the potential safety concerns for ARIA (amyloid related imaging abnormalities) remain as significant concerns for the medical community, but will only be addressed with long-term real-world data, thus, we should see more clarity on these in the next few years.

For more information on any of these topics, please feel free to reach out to info@lifesciencedynamics.com

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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