FDA Approves Modified Dosing for Lilly's Alzheimer's Drug Kisunla, Addressing Safety Concerns
Eli Lilly's Alzheimer's disease drug Kisunla has received FDA approval for a modified dosing schedule, aimed at reducing the risk of a dangerous side effect while maintaining efficacy. This development comes as the pharmaceutical industry continues to grapple with the challenges of treating Alzheimer's disease effectively and safely.
New Dosing Regimen Reduces Brain Swelling Risk
The Food and Drug Administration has given the green light to a new dosing protocol for Kisunla, which allows for a more gradual increase in dosage. This modified regimen starts with a single 350 milligram vial for the first monthly intravenous infusion, followed by two vials for the second dose, three vials for the third, and then the full four-vial dose from the fourth month onward.
This adjustment is based on results from the Trailblazer-Alz 6 study, which demonstrated a significant reduction in the incidence of amyloid-related imaging abnormalities with edema and effusion (ARIA-E), a form of brain swelling associated with anti-amyloid antibodies. The study found that patients receiving the modified dosing experienced a 41% lower risk of ARIA-E at 24 weeks compared to those on the original regimen (14% vs. 24% incidence).
Dr. Brandy Matthews, Lilly's vice president for Alzheimer's medical affairs, stated, "The results of the study can have really significant and positive implications for both healthcare professionals and patients as they're engaging in these benefit-risk discussions related to the initiation of Kisunla."
Market Dynamics and Regulatory Landscape
Kisunla, approved in 2024, is one of only two disease-modifying Alzheimer's drugs currently on the market, alongside Eisai and Biogen's Leqembi. Both drugs target and remove amyloid beta plaques in the brain, which are believed to play a role in the progression of Alzheimer's disease.
Despite their potential, these drugs have faced challenges in market adoption. In the first quarter of 2025, Kisunla reported global sales of $21.5 million, while Leqembi achieved $96 million. The modest uptake is partly attributed to safety concerns and the need for complex diagnostic procedures.
The regulatory landscape for these drugs remains complex. While the FDA has supported their use, European regulators have been more cautious. The European Medicines Agency initially rejected Kisunla, citing ARIA risks, but is currently re-evaluating the drug.
Implications for Alzheimer's Treatment
The approval of this new dosing regimen for Kisunla represents a significant step in addressing the safety concerns that have hindered the widespread adoption of anti-amyloid therapies. By potentially improving the benefit-risk profile, this development may aid healthcare professionals in making more informed treatment decisions for their patients with early Alzheimer's disease.
As the pharmaceutical industry continues to invest in Alzheimer's research, with Global Data reporting a 780% jump in deal value for Alzheimer's-focused companies from 2022 to 2024, the field remains dynamic. Ongoing trials, such as Lilly's Trailblazer-Alz3 study evaluating Kisunla in preclinical Alzheimer's, may further shape the treatment landscape in the coming years.
References
- Lilly gets FDA OK of modified dosing for Alzheimer’s drug
A slower ramp-up of Kisunla dosing lowers the rate of dangerous brain swelling, a risk that has made doctors reluctant to prescribe Lilly’s amyloid-busting drug.
- Lilly Gets FDA Label Update for Alzheimer’s Drug To Mitigate Safety Concerns
The FDA will allow a new dosing schedule for Eli Lilly’s Alzheimer’s drug Kisunla that could lessen a known side effect of the monoclonal antibody drug class that has led to several deaths.
- Eli Lilly's Kisunla wins FDA nod for new dosing with fewer side effects in Alzheimer's
The benefit-risk balance is tipping more in favor of Eli Lilly’s Kisunla in early Alzheimer’s disease as the FDA approves a new dosing regimen of the drug with an improved safety profile.
Explore Further
What were the key findings of the Trailblazer-Alz 6 study other than the reduction in ARIA-E risk?
How do Kisunla's sales figures compare to those of its competitors in other regions besides the first quarter of 2025?
What are the specific factors causing the European Medicines Agency to re-evaluate Kisunla?
What implications does the new dosing regimen have for future regulations and approvals of Alzheimer's drugs in global markets?
How are ongoing studies like Trailblazer-Alz3 expected to impact Kisunla's market position in the coming years?