FORT DETRICK, Md. – October 23, 2020 –
Yesterday, the U.S. Food and Drug Administration (FDA) approved Gilead Sciences, Inc.’s Veklury® (Remdesivir) for treatment of hospitalized COVID-19 patients who are 12 years of age or older and weigh at least 40 kilograms (88 lbs). The approval of Veklury® was supported by the agency’s analysis of data from three randomized, controlled clinical trials that included patients hospitalized with mild to severe COVID-19. Remdesivir is the first FDA-approved COVID-19 treatment and is widely available in hospitals across the U.S.
While Remdesivir previously received an FDA Emergency Use Authorization (EUA) allowing for the drug’s immediate use to treat severe COVID-19 infection on May 1, and expanded the EUA later in August for the treatment of all hospitalized COVID-19 patients regardless of the severity of their symptoms, this approval indicates that the drug has been deemed safe and effective by the world’s leading regulatory agency for the treatment of a larger patient population
The DOD’s Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense’s (JPEO-CBRND) Joint Project Manager for Chemical, Biological, Radiological and Nuclear Medical (JPM CBRN Medical), along with the Defense Threat Reduction Agency’s Joint Science and Technology Office (DTRA-JSTO), supported Gilead’s Remdesivir from the early stages of research and development, initially investing in the development of a broad-spectrum antiviral that would treat filoviruses such as Ebola and Marburg viruses. The JPM CBRN Medical also worked with the Force Health Protection branch of the U.S. Army Medical Materiel Development Activity to field the drug as an investigational product used to treat COVID-19 in military personnel worldwide, prior to FDA approval.
The existing relationship with this industry partner, along with the contributions of the JPEO-CBRND’s technical team—who leveraged the organization’s rapid contracting capability, requested submissions from across the industry, and then reviewed over 500 white papers—accelerated efforts to repurpose Remdesivir as a COVID-19 treatment. Repurposing, in concert with novel drug development efforts, enables a multi-layered defense approach for effective medical countermeasure development and delivery to the warfighter.
“We are pleased that the FDA approved Remdesivir for COVID-19 treatment and that our organization added value to this global fight through its early support of this critical drug’s development,” said Douglas Bryce, the Joint Program Executive Officer for Chemical, Biological, Radiological and Nuclear Defense. “Our team’s unparalleled technical expertise enabled the rapid identification and analysis of an existing DOD capability, which can now be used broadly to combat this disease. FDA approval of Remdesivir for COVID-19 treatment will also aid in streamlining the further development of this broad-spectrum antiviral for other indications that threaten our service members, making it a worthwhile and smart DOD investment.”
About the JPEO-CBRND: The Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) protects the Joint Force by providing medical countermeasures and defense equipment against chemical, biological, radiological and nuclear (CBRN) threats. JPEO-CBRND’s goal is to enable the Joint Force to fight and win unencumbered by a CBRN environment. JPEO-CBRND facilitates the rapid response, advanced development, manufacturing and acquisition of medical solutions, such as vaccines, therapeutics, and diagnostics, to combat CBRN and emerging threats such as COVID-19. To learn more about JPEO-CBRND’s COVID-19 response, visit https://www.jpeocbrnd.osd.mil/coronavirus or follow JPEO-CBRND on social media at @JPEOCBRND.