#None #Alzheimer's #Eli Lilly #Donanemab

Donanemab Receives Positive CHMP Opinion for Early Symptomatic Alzheimer's Disease

Eli Lilly and Company has announced a significant advancement in Alzheimer's treatment with the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) issuing a positive opinion regarding donanemab. This recommendation is for treating early symptomatic Alzheimer's disease in adults who have confirmed amyloid pathology and are either apolipoprotein E ε4 (ApoE4) heterozygotes or non-carriers. With the European Commission expected to deliver a regulatory decision soon, the development marks a crucial milestone in the ongoing effort to provide effective therapies for Alzheimer’s patients across Europe.

Patrik Jonsson, executive vice president and president of Lilly International, expressed enthusiasm about the positive opinion, stating, "This significant milestone brings us closer to offering donanemab to patients who need it most. This potential treatment could profoundly impact the lives of those living with early symptomatic Alzheimer's, and we remain dedicated to advancing its development through clinical trials and additional programs."

Currently, Alzheimer's disease is a major public health concern in Europe, affecting approximately 6.9 million individuals. This number is projected to nearly double by 2050 due to an aging population. Notably, about one-third of individuals experiencing mild cognitive impairment or mild dementia attributed to Alzheimer's disease may progress to a more advanced stage within one year. This supports the urgency in developing effective treatments like donanemab.

The CHMP's favorable opinion is primarily based on the data gathered from the TRAILBLAZER-ALZ 2 clinical trial, which demonstrated that donanemab significantly slows cognitive and functional decline, along with reducing the risk of moving to the next clinical stage of the disease. Furthermore, the TRAILBLAZER-ALZ 6 trial assessed a modified dosing schedule, which notably reduced side effects related to amyloid-related imaging abnormalities with edema/effusion (ARIA-E) when compared to the original dosing regimen used in TRAILBLAZER-ALZ 2. Importantly, this modified schedule still achieved comparable levels of amyloid plaque removal and reductions in P-tau217 levels.

While ARIA is commonly symptomless, it can lead to serious, potentially life-threatening symptoms. Those with one or two copies of the ApoE4 gene are at a heightened risk for developing Alzheimer's disease and experiencing ARIA. For this reason, it is vital for patients to discuss any safety concerns with their healthcare providers prior to starting treatment.

Donanemab is marketed as Kisunla in several countries, including the United States, Japan, China, the United Kingdom, and Australia, among others. In many regions, its use is approved for patients irrespective of their ApoE4 status. Notably, donanemab is the only therapy targeting amyloid plaques that demonstrates evidence for ceasing treatment once amyloid plaques are cleared, potentially leading to lower treatment costs and lesser infusion frequency.

Conclusion

The positive CHMP opinion for donanemab is a hopeful indicator for the future of Alzheimer’s treatment in Europe. As the drug awaits regulatory approval from the European Commission, the medical community and patients alike are anticipating a new option that may engage effectively with the complexities of early symptomatic Alzheimer's disease. With Alzheimer’s rates on the rise, advancements like donanemab could change the trajectory of care for millions afflicted by this challenging condition. Lilly's commitment to ongoing research remains reassuring as we look forward to the potential availability of this therapy in the near future.