New news in the fight against Alzheimer’s disease. The Medicines and Healthcare products Regulatory Agency has approved the licence for donanemab (marketed as Kisunla) for use in the early stages of the condition. This approval today marks a crucial step forward in treating this debilitating neurological disorder.
What is Donanemab?
Donanemab is a disease-modifying treatment developed by Eli Lilly, designed to slow down the progression of Alzheimer’s disease by targeting the amyloid protein, which is believed to be a key contributor to the disease.
Unlike existing treatments that only alleviate symptoms, donanemab works by removing beta-amyloid plaques from the brain, thereby reducing the toxic effects on brain cells.
How Does Donanemab Work?
Donanemab is administered intravenously and functions as an immunotherapy drug, thereby leveraging the body’s natural defense mechanisms.
Specifically, it instructs the body’s immune system to recognize and remove amyloid beta proteins, which subsequently form harmful plaques in the brains of individuals with Alzheimer’s disease. Moreover, by targeting these proteins, Donanemab effectively disrupts the progression of Alzheimer’s pathology.
The drug has shown promising results in clinical trials, particularly when administered early in the disease course.
In the Phase III TRAILBLAZER-ALZ2 trial, donanemab slowed the decline in memory and thinking by more than 20% and reduced the decline in everyday activities by 40% over 18 months.
Eligibility and Approval Criteria
The Medicines and Healthcare products Regulatory Agency approval specifies that donanemab is licensed for adult patients in the early stages of Alzheimer’s disease who have one or no copies of the apolipoprotein E4 (ApoE4) gene.
This gene is associated with an increased risk of developing Alzheimer’s disease. Patients with two copies of the ApoE4 gene, known as homozygous patients, are not recommended for this treatment due to increased risks.
Clinical Trial Outcomes
NHS Accessibility and Cost-Effectiveness
Despite the Medicines and Healthcare products Regulatory Agency approval, donanemab faces hurdles before it can be widely available on the National Health Service. The National Institute for Health and Care Excellence has to review the drug’s cost-effectiveness.
Recent draft recommendations from NICE suggest that donanemab, like its predecessor lecanemab, does not currently prove value for the NHS due to its high costs.
Helen Knight from NICE emphasized that while the drug delays cognitive deterioration, the benefit is not sufficient to warrant the increased costs for the NHS.
Safety and Monitoring
The approval of donanemab comes with strict safety monitoring. Doctors should not prescribe the drug to patients taking anticoagulants or those diagnosed with cerebral amyloid angiopathy.
Future Implications
The approval of donanemab represents a significant advancement in the treatment of Alzheimer’s disease. However, the journey to making these treatments accessible to all who need them is ongoing.
As Julian Beach, Medicines and Healthcare products Regulatory Agency Interim Executive Director, noted,
“Licensing medicines which meet acceptable standards of safety, quality and efficacy is a key priority for us.”
Main Points at a Glance
- MHRA Approval: Donanemab licensed for early-stage Alzheimer’s disease treatment.
- Eligibility: Patients with one or no copies of the ApoE4 gene.
- Administration: Intravenous immunotherapy.
- Clinical Trials: Significant delay in disease progression observed.
- NHS Accessibility: NICE review pending due to cost-effectiveness concerns.
- Safety Monitoring: Post-authorisation safety study to be conducted.
Closing Thoughts
The approval of donanemab marks a hopeful milestone in the fight against Alzheimer’s disease, offering a potential slowdown in the progression of the condition for those in its early stages.
However, the path to widespread NHS accessibility remains challenging due to cost-effectiveness concerns.
As we move forward, the question remains:
Will advancements in medical research and regulatory processes eventually make disease-modifying treatments like donanemab accessible to all who need them, or will cost barriers continue to limit their reach?
Sources: THX News & Medicines and Healthcare products Regulatory Agency.
