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January 24, 2023

Around the nation: FDA declines accelerated approval for Eli Lilly's Alzheimer's drug

Daily Briefing

    Eli Lilly on Thursday announced that FDA rejected its application for accelerated approval of its Alzheimer's drug, in today's bite-sized hospital and health industry news from California, Illinois, and Indiana.

    • California: Healthcare interoperability software provider Health Gorilla released a report that found over half of technology leaders at top U.S. health systems are increasing investment in interoperability initiatives in 2023. For the report, Health Gorilla surveyed 40 chief information officers and chief medical information officers from the top 50 health systems in the United States by net patient revenue. Overall, 55% of executives said they plan to increase their organization's investment in interoperability initiatives this year by 5% to 20%, compared to 2022. In addition, 2% of executives said they plan to increase their investment by 20% or more. None of the executives said their year-over-year investment in interoperability initiatives would decrease, but 43% said it would not change. "As an industry, we clearly have work to do on data quality. Ironically, the more progress we make on interoperability, the more duplicative data we will need to deal with, as all record sources for a particular patient will converge on a shared understanding of that patient's history. Interoperability services must be able to sift through this duplication in order to make data meaningful, rather than just passing duplication along to the user," said Dave Cassel, SVP of operations at Health Gorilla. (Adams, MedCity News, 1/22)
    • Illinois: The Department of Justice (DOJ) launched an investigation into Abbott Laboratories and its infant formula plant in Sturgis, Michigan, which was temporarily closed last year after Abbott Nutrition recalled several formula brands over reports of bacterial infections. In an FDA report, officials stated that conditions at the plant "were not consistent with a strong food safety culture," including insufficient hand-washing practices and evidence of previous bacterial contamination. Following the monthslong closure in 2022, Abbott Nutrition came to an agreement with FDA to reopen the Michigan plant. Under the deal, Abbott is required to consult outside expert help to keep the plant in proper condition. "The DOJ has informed us of its investigation, and we're cooperating fully," said Abbott spokesperson Scott Stoffel. (Chen, Axios, 1/20)
    • Indiana: Eli Lilly on Thursday announced that FDA rejected its application for accelerated approval of its Alzheimer's drug, donanemab, citing a lack of data from patients who have been treated with the drug. In a "complete response letter" from FDA, the agency said it wanted to see safety data on at least 100 patients in clinical trials who have been treated with the drug for a minimum of 12 consecutive months. "While the trial included more than 100 patients treated with donanemab, due to the speed of plaque reduction, many patients were able to stop dosing as early as six months of treatment, resulting in fewer than 100 patients receiving 12 months of donanemab," Lilly said. "The FDA indicated that the data to meet the exposure expectation would likely need to include the unblinded controlled safety data from TRAILBLAZER-ALZ 2 upon completion." (Vinluan, MedCity News, 1/19; McGinley, Washington Post, 1/19)

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