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Invited Commentary
May 1, 2023

Xuebijing Injection for the Treatment of Sepsis: What Would a Path to FDA Approval Look Like?

Author Affiliations
  • 1Hyman, Phelps and McNamara, PC, Washington, DC
JAMA Intern Med. 2023;183(7):655-657. doi:10.1001/jamainternmed.2023.0788

Sepsis is a serious condition with high morbidity and mortality for which treatment advancements are desperately needed. In this issue of JAMA Internal Medicine, Liu et al1 describe the results of Efficacy of Xuebijing Injection in Patients With Sepsis (EXIT-SEP), a large, multicenter, single-country, double-blind, placebo-controlled randomized clinical trial of Xuebijing injection (XBJ), an intravenous herbal preparation, for the treatment of sepsis. With more than 900 patients in each treatment group, 28-day all-cause mortality was 18.8% in the XBJ group and 26.1% in the placebo group, for an absolute risk difference of 7.3 (95% CI, 3.4-11.2) percentage points (P < .001). These results are certainly intriguing; one might wonder how an herbal preparation such as XBJ might gain US marketing approval. Major issues include (1) XBJ is an herbal preparation and not a drug; (2) there is only a single efficacy study; and (3) the EXIT-SEP trial was conducted entirely outside the US, in 1 country (China).

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