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.”
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. For information about the authorized use of remdesivir and mandatory requirements of the Emergency Use Authorization in the U.S., please review the Fact Sheet for Healthcare Providers and FDA Letter of Authorization available at www.gilead.com/remdesivir.
Forward Looking Statement
This statement includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, that are subject to risks, uncertainties and other factors. Remdesivir is an investigational drug that has not been approved by the FDA for any use, and it is not yet known if remdesivir is safe or effective for the treatment of COVID-19. There is the possibility of unfavorable results from ongoing and additional clinical trials involving remdesivir and the possibility that Gilead and other parties may be unable to complete one or more of such trials in the currently anticipated timelines or at all. Further, it is possible that Gilead may make a strategic decision to discontinue development of remdesivir or that FDA and other regulatory agencies may not approve remdesivir, and any marketing approvals, if granted, may have significant limitations on its use. As a result, remdesivir may never be successfully commercialized. In addition, Gilead may face challenges related to the allocation and geographical distribution of existing and future supply of remdesivir. If Gilead and its manufacturing partners are unable to sufficiently scale up the production of remdesivir in the currently anticipated timelines, Gilead may be unable to meet global supply needs. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s periodic reports filed with the U.S. Securities and Exchange Commission, including current reports on Form 8-K, quarterly reports on Form 10-Q and annual reports on Form 10-K. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.