October 9, 2020

Covid-19 roundup: Eli Lilly, Regeneron seek emergency use authorizations for Covid-19 treatments

Daily Briefing
    • Alex Gorsky, CEO of Johnson & Johnson, during an interview on Bloomberg Television last week said he expects that "by late this year, early next year, [the company] should be in a position to begin reviews with regulatory authorities to see if [its coronavirus vaccine candidate] is in fact safe, effective, and something that could be considered for an emergency use authorization." Gorsky also said the company will rely on data generated by the company's late-stage clinical trials on its experimental vaccine when evaluating whether the candidate is ready for regulatory review. "It's absolutely critical during a time when unfortunately, everything becomes politicized, that we rely on data, we rely on science, we rely on well-established regulatory guidelines to guide all of our decisions on the development and actual utilization of these vaccines," he said (Griffin, Bloomberg, 10/2).

    • Eli Lilly and Regeneron on Wednesday separately announced that they've applied for emergency use authorizations (EUAs) from FDA for experimental Covid-19 treatments. Eli Lilly said it's seeking an EUA for its experimental antibody treatment, which the company claimed can help reduce coronavirus levels in patients with mild-to-moderate cases of Covid-19. Meanwhile, Regeneron said it's seeking an EUA for its experimental antibody cocktail, which was recently used and touted by President Trump. According to Regeneron, the treatment features two antibodies intended to help improve the immune system's response to the novel coronavirus. Regeneron said the treatment so far has shown promising early results, but the company noted that clinical trials on the treatment have not yet finished (Mishra/O'Donnell, Reuters, 10/7; Loftus, Wall Street Journal, 10/7; Thomas, New York Times, 10/7).

    • FDA has granted an EUA to an artificial intelligence (AI) tool developed by Dascena that aims to predict whether a hospitalized Covid-19 patient is at risk of needing intubation. According to Dascena, a study of 197 Covid-19 patients at five health systems in the United States showed that the AI tool performed better on a number of measures than the Modified Early Warning Score, which is a non-AI system that's currently used by clinicians treating Covid-19 patients (Robbins, STAT+, 10/5 [subscription required]).

    • Mount Sinai announced that it will use Apple's Apple Watch, in conjunction with a smartphone app and survey questions, to study how America's coronavirus epidemic is affecting health care workers psychologically. According to Robert Hirten and Zahi Fayad from the Mount Sinai Covid Informatics Center, the study will focus not just on frontline health care workers, but on medical workers serving in a variety of occupations. "We didn't want to focus on a specific group of health care workers," Hirten said. "We wanted to assess the psychological stress across the spectrum so we can really see who the groups of people are who might be most in need of help." The key data they will extract from the Apple Watch is variation in heart rate, which is associated with stress levels and disease risk, Hirten and Fayad said (Jercich, Healthcare IT News, 9/30).

    • The University of Minnesota (UM) and M Health Fairview have developed an AI algorithm that can diagnose potential Covid-19 cases by evaluating chest X-rays. To build the algorithm, UM and M Health Fairview analyzed 100,000 de-identified X-rays of patients without Covid-19 and 18,000 X-rays of patients with the disease. The university has made the algorithm available at no cost to any health system that uses Epic EHRs (Drees, Becker's Health IT, 10/2).
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