Gilead's New Analysis On Remdesivir Shows Improved Clinical Recovery And Reduced Risk Of Death

Gilead Sciences Inc. (GILD) said additional data from a late-stage study demonstrated that its antiviral remdesivir significantly improved clinical recovery and a 62 percent reduction in the risk of mortality in Covid-19 patients compared to standard of care.

Gilead said the mortality data point is an important finding that requires confirmation in prospective clinical trials.

The comparative pre-planned analysis included 312 patients treated in the Phase 3 SIMPLE-Severe study and a separate real-world retrospective cohort of 818 patients with similar baseline characteristics and disease severity who received standard of care treatment in the same time period as the SIMPLE-Severe study.

The company said findings from the comparative analysis showed that 74.4 percent of remdesivir-treated patients recovered by Day 14 versus 59.0 percent of patients receiving standard of care.

The mortality rate for patients treated with remdesivir in the analysis was 7.6 percent at Day 14 compared with 12.5 percent among patients not taking remdesivir.

remdesivir is being tested as a specific treatment for COVID-19, and has been authorized for emergency use in the US, India, Singapore, and approved for use in Japan and the European Union for people with severe symptoms.

Meanwhile, Gilead is presenting new analyses of the company's compassionate use program, which demonstrated that 83 percent of pediatric patients and 92 percent of pregnant and postpartum women with a broad spectrum of disease severity recovered by Day 28. No new safety signals were identified with remdesivir across these populations.

Gilead recently announced the initiation of a global, open-label Phase 2/3 trial to evaluate the safety, tolerability and pharmacokinetics of remdesivir in pediatric patients from birth to less than 18 years of age. Gilead is also collaborating on a study for pregnant women.

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