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INDIANAPOLIS - The U.S. Food and Drug Administration has approved a label update with a new recommended titration dosing schedule for Eli Lilly and Company’s (NYSE:LLY) Alzheimer’s treatment Kisunla, according to a press release statement issued Wednesday. The pharmaceutical giant, with a market capitalization of $698 billion and impressive revenue growth of 36% over the last twelve months, continues to strengthen its position as a prominent player in the pharmaceutical industry. According to InvestingPro analysis, Eli Lilly maintains strong financial health with an industry-leading gross profit margin of 81.7%.
The modified titration schedule for donanemab-azbt significantly reduced the incidence of amyloid-related imaging abnormalities with edema/effusion (ARIA-E) compared to the original dosing regimen. The new schedule lowered ARIA-E rates by 41% at 24 weeks and 35% at 52 weeks while maintaining similar levels of amyloid plaque removal. For detailed analysis of Eli Lilly’s pipeline and growth potential, investors can access comprehensive research through InvestingPro, which offers exclusive insights and 13 additional ProTips about the company’s performance and outlook.
The new dosing recommendation shifts a single vial from the first dose to the third dose, delivering the same amount of medication by week 24. This adjustment does not compromise the treatment’s ability to reduce amyloid plaque or alter its once-monthly dosing schedule.
In the TRAILBLAZER-ALZ 6 study supporting the label update, patients receiving the modified titration experienced a 14% incidence of ARIA-E by week 24 compared to 24% for those on the original dosing regimen. At week 52, ARIA-E rates were 16% versus 25%, respectively.
Amyloid plaque levels in patients on the modified titration were reduced on average by 67% from baseline at 24 weeks, comparable to the 69% reduction observed with the original dosing regimen.
Kisunla was initially approved by the FDA in July 2024 based on the TRAILBLAZER-ALZ 2 Phase 3 clinical trial data, which demonstrated the drug slowed cognitive and functional decline in early symptomatic Alzheimer’s disease patients.
The medication is administered as an intravenous infusion once every four weeks and is indicated for adults with early symptomatic Alzheimer’s disease, including those with mild cognitive impairment and mild dementia, with confirmed amyloid pathology.
In other recent news, Eli Lilly has been in the spotlight with several significant developments. The company is set to report its second-quarter earnings, with JPMorgan projecting total quarterly sales of $14.8 billion, which is $370 million above consensus estimates. This anticipated growth is largely driven by the strong performance of its weight loss and diabetes medications, Mounjaro and Zepbound. UBS has maintained its buy rating on Eli Lilly, citing the company’s leadership in the obesity treatment market and expecting its quarterly sales to surpass consensus by 2%. Meanwhile, Eli Lilly has announced a definitive agreement to acquire Verve Therapeutics for up to $1.3 billion, with the deal expected to close by the third quarter of 2025. Evercore ISI has maintained an In Line rating for Eli Lilly following positive clinical trial results for bimagrumab, a weight loss treatment. Additionally, Eli Lilly declared a quarterly dividend of $1.50 per share for the third quarter of 2025. These recent developments underscore Eli Lilly’s ongoing strategic initiatives and financial activities.
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