Lilly's Kisunla Receives FDA Approval for Updated Label

Eli Lilly and Company, a leading pharmaceutical group, has received FDA approval for an updated label for Kisunla, a drug used to treat osteoporosis. Kisunla is part of Eli Lilly's endocrinology portfolio, which accounts for 65.5% of the company's net sales. The updated label aims to improve the drug's efficacy and safety profile.

Eli Lilly and Company (NYSE: LLY) has received approval from the U.S. Food and Drug Administration (FDA) for an updated label of Kisunla, a drug used to treat osteoporosis. The update aims to improve the drug's efficacy and safety profile, aligning with the company's ongoing commitment to patient care and innovation. This approval is part of Eli Lilly's broader strategy to enhance its endocrinology portfolio, which accounts for 65.5% of the company's net sales [1].

The updated label introduces a new dosing regimen for Kisunla, which is designed to lower the incidence of adverse events, particularly amyloid-related imaging abnormalities with edema/effusion (ARIA-E). The FDA approval comes on the heels of the TRAILBLAZER-ALZ 6 study, which demonstrated that the modified titration schedule significantly lowered ARIA-E rates compared to the original dosing schedule. This study involved 843 participants with early symptomatic Alzheimer's disease and was published in Alzheimer's and Dementia [1].

The new dosing regimen involves a more gradual titration, shifting a single vial from the first dose to the third dose. This adjustment resulted in lower rates of ARIA-E without compromising Kisunla's ability to reduce amyloid plaque or its once-monthly dosing. The study showed a 41% lower incidence of ARIA-E at 24 weeks and a 35% lower incidence at 52 weeks compared to the original dosing regimen [1].

Eli Lilly's Vice President of Global & US Medical Affairs for Alzheimer's Disease, Brandy Matthews, MD, FAAN, stated, "We are confident that this label update for Kisunla will significantly aid healthcare professionals in evaluating appropriate treatment options for their patients." The company underscores its commitment to patient safety and the advancement of Alzheimer's disease treatment by potentially mitigating the risk of ARIA-E [1].

The U.S. FDA approved Kisunla in July 2024 based on the TRAILBLAZER-ALZ 2 Phase 3 clinical trial data, which demonstrated that Kisunla significantly slowed cognitive and functional decline in patients with early symptomatic Alzheimer's disease [1]. Lilly continues to study donanemab in multiple clinical trials, including TRAILBLAZER-ALZ 3 and TRAILBLAZER-ALZ 5, to further evaluate its potential in treating Alzheimer's disease [1].

This approval is a significant milestone for Eli Lilly, highlighting the company's dedication to improving the safety and efficacy of its therapeutic offerings. Investors and financial professionals should closely monitor the impact of this approval on Eli Lilly's financial performance, particularly within its endocrinology portfolio.

References:
[1] https://www.marketscreener.com/quote/stock/ELI-LILLY-AND-COMPANY-13401/news/FDA-approves-updated-label-for-Lilly-s-Kisunla-donanemab-azbt-with-new-dosing-in-early-symptomatic-50468232/