Foster City, Calif., June 1, 2020 – Gilead Sciences today issued the following statement from Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences, on the totality of clinical data on remdesivir to date:
“Since the earliest days of the outbreak, Gilead has been focused on rapidly studying the potential for our investigational antiviral remdesivir to treat patients with COVID-19. We set out to answer important questions about if, how and when to use remdesivir, conducting multiple studies in parallel and on a significantly compressed timeline, given the urgency of the public health need. Building on a foundation of knowledge from our earlier studies of remdesivir in other viruses, we have conducted one of the fastest ever late-stage development programs to bring forward a potential treatment for COVID-19.
With the latest data announced today, we now have three randomized, controlled clinical trials demonstrating that remdesivir improved clinical outcomes by several different measures. Today’s SIMPLE-Moderate study results showed that when treating patients with moderate disease – those with pneumonia who do not require supplemental oxygen – a 5-day course of remdesivir led to greater clinical improvement than standard of care alone. The placebo-controlled study conducted by the National Institute of Allergy and Infectious Diseases demonstrated that remdesivir enabled more rapid recovery and that earlier treatment improved outcomes in patients with a range of disease severity. And our earlier SIMPLE-Severe study results showed that when treating patients with severe disease – those who require non-invasive supplemental oxygen – 5 days of remdesivir led to similar improvements as a 10-day course. The totality of clinical data shows that remdesivir has the potential to meaningfully benefit patients with COVID-19 and offers important hope.
With the additional data we have in hand today, we will continue to pursue research opportunities to evaluate patient outcomes and potentially benefit more patients with remdesivir. These include extending treatment earlier in the course of disease, combination studies with other therapies for the most critically ill patients, pediatric studies and the development of alternate formulations. We will continue to share emerging data with regulatory authorities as we work together to help address the needs of patients around the world.
We would like to thank the patients and healthcare providers who have participated in clinical trials of remdesivir to date. It is thanks to the collaboration of everyone involved that we have so rapidly advanced our understanding of remdesivir as a potential COVID-19 treatment.”
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 http://www.gilead.com/remdesivir.
This press release 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. 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 Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.