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GILEAD SCIENCES STATEMENT ON NEJM PUBLICATION OF REMDESIVIR DATA FROM NIAID STUDY

Foster City, Calif., May 22, 2020 – Gilead Sciences today issued the following statement from Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences, on data from the National Institute of Allergy and Infectious Diseases’ (NIAID) study of our investigational antiviral drug remdesivir, published in The New England Journal of Medicine (NEJM): 

“We are pleased that the findings from the NIAID trial of remdesivir in hospitalized patients with advanced COVID-19 have been published in a peer-reviewed medical journal. These findings support the use of remdesivir in this population, with the largest benefit observed among individuals who required oxygen supplementation but were not mechanically ventilated. We anticipate that results from our Phase 3 SIMPLE-Severe study, which is evaluating remdesivir in a similar population of COVID-19 patients requiring oxygen but not on mechanical ventilation, will be published in the near future. These data from the SIMPLE-Severe study support treatment of some patients for 5 days rather than 10 days, depending on clinical status. 

Additionally, results from our Phase 3 SIMPLE-Moderate study, which is evaluating remdesivir in hospitalized patients with COVID-19 and lung involvement not requiring oxygen supplementation, are expected at the end of this month. This study should provide more information on the utility of 5 or 10 days of remdesivir versus standard of care in patients with earlier stages of disease. 

Beyond the ongoing studies of remdesivir, we look forward to the initiation of combination studies of remdesivir to understand whether the addition of other drugs may enhance patient outcomes. Gilead is committed to continued studies of remdesivir to further advance our understanding of patient care for the treatment of COVID-19, and we remain engaged with governments and regulatory agencies around the world to help respond to this urgent public health emergency.” 

About Remdesivir 

Remdesivir is an investigational antiviral drug that is being studied in multiple ongoing international clinical trials, and the safety and efficacy of remdesivir for the treatment of COVID-19 are not yet established. Remdesivir has not been approved by the U.S. FDA for any use.