FDA Approves New Alzheimer’s Treatment, Donanemab from Eli Lilly

The FDA has approved a new Alzheimer’s treatment called donanemab, marketed as Kisunla by Eli Lilly. This approval marks the third drug in a new class aimed at slowing brain decline in early-stage Alzheimer’s patients.

Approval and Availability

After years of challenges and delays, Eli Lilly announced that Kisunla will be available within weeks following the FDA’s approval. This new treatment offers hope for patients who urgently need effective options.

Importance of Early Treatment

Anne White, president of Eli Lilly’s neuroscience division, emphasized the significance of early treatment, stating, “Kisunla demonstrated very meaningful results for people with early symptomatic Alzheimer’s disease. We know these medicines have the greatest potential benefit when people are treated earlier in their disease.”

Previous Setbacks

Last year, the FDA denied Eli Lilly’s request for accelerated approval due to concerns about long-term safety. However, after submitting additional data, the FDA’s advisory committee unanimously voted in favor of the drug’s benefits outweighing its risks.

How Donanemab Works

Donanemab is an anti-amyloid monoclonal antibody that targets and removes amyloid plaques in the brain, which are linked to Alzheimer’s disease. Patients receive intravenous infusions every four weeks, and many can stop treatment after about six months based on brain scans.

Comparisons to Other Treatments

The only other similar treatment on the market is lecanemab (Leqembi), developed by Eisai and Biogen. Donanemab’s infusions are shorter and less frequent, and patients can potentially stop treatment sooner, reducing costs and the number of infusions.

Cost of Treatment

Eli Lilly announced that Kisunla will cost around $32,000 for a year’s treatment. However, the actual cost will vary depending on the duration of treatment, which ranges from six to eighteen months based on patient response.

Insurance Coverage

For patients with Medicare Part B, donanemab will be covered similarly to lecanemab, with a 20% coinsurance after meeting their deductible. Patients will need to get the drug from doctors enrolled in a study gathering data on its effectiveness.

Effectiveness

Eli Lilly measured donanemab’s effectiveness using scales to assess cognitive and functional decline. Patients who received the drug showed a 22% slower decline compared to those who received a placebo, effectively prolonging the progression to the next stage of Alzheimer’s.

Side Effects

Donanemab, like other anti-amyloid treatments, carries a warning about amyloid-related imaging abnormalities. These abnormalities, seen in about a quarter of participants, can occasionally lead to serious issues like brain function problems and seizures. Some trial participants experienced reactions to the infusion, with common symptoms including chills, nausea, and headaches.

Conclusion

Donanemab offers a promising new option for early-stage Alzheimer’s patients, providing effective treatment with fewer infusions and potentially lower costs. Continued research and monitoring will help refine its use and improve patient outcomes.

References

• FDA Press Release
• Eli Lilly News Release
• Clinical Trial Data