Eli Lilly's Kisunla Receives FDA Label Update to Reduce ARIA-E Incidence by 35-41%

Strategic Insights -

Eli Lilly and Company has announced that the US Food and Drug Administration (FDA) has approved a label update for Kisunla (donanemab-azbt), a once-monthly amyloid-targeting therapy for adults with early symptomatic Alzheimer's disease. The updated label includes a new recommended titration dosing schedule, which has been shown to lower the incidence of amyloid-related imaging abnormalities with edema/effusion (ARIA-E) by 35-41% at 24 and 52 weeks, respectively.

Key Takeaways:

  • The new recommended dosing regimen for Kisunla involves a more gradual titration, shifting a single vial from the first dose to the third dose, which resulted in lower rates of ARIA-E without compromising the therapy's ability to reduce amyloid plaque or its once-monthly dosing.
  • The TRAILBLAZER-ALZ 6 study showed that the incidence of ARIA-E was 14% in patients receiving the modified titration compared to 24% for those receiving the original dosing regimen, a 41% lower relative risk.
  • At week 52, the incidence of ARIA-E was 16% in patients receiving the modified titration compared to 25% for those receiving the original dosing regimen, a 35% lower relative risk.
  • Patients on the modified titration experienced a reduction of amyloid plaque and P-tau217 comparable to patients receiving the original dosing regimen.
  • Higher rates of hypersensitivity reactions and infusion-related reactions were observed in the modified titration group.
  • The updated dosing strategy is a meaningful advancement for patients and their care teams, offering greater confidence in the safety of Kisunla while preserving its ability to reduce amyloid.
  • Lilly Support Services for Kisunla provides essential services, including coverage determination assistance, care coordination, nurse navigator support, and personalized resources, to assist patients throughout their treatment journey.

Statistics:

  • The incidence of ARIA-E was 14% in patients receiving the modified titration compared to 24% for those receiving the original dosing regimen.
  • The incidence of ARIA-E at week 52 was 16% in patients receiving the modified titration compared to 25% for those receiving the original dosing regimen.
  • The number of patients with ARIA-E was significantly lowered by 41% at 24 weeks and by 35% at 52 weeks.
  • Amyloid plaque levels were reduced on average 67% from baseline in patients on the modified titration of donanemab in TRAILBLAZER-ALZ 6 compared to 69% for patients on the original dosing regimen.

Sources:

  • Eli Lilly and Company. Press Release. July 2024.
  • TRAILBLAZER-ALZ 6 study.
  • TRAILBLAZER-ALZ 2 Phase 3 clinical trial data.