Gilead Sciences Update on Supply and Distribution of Veklury® (remdesivir) in the United States
-- Supply of Veklury Is Meeting Real-Time Demand in the
-- Clinical Benefits of Veklury Consistently Demonstrated Across Three Randomized, Clinical Trials Are Now Available to All Clinically Appropriate Hospitalized COVID-19 Patients in the
-- Veklury Distribution Has Transitioned from the
Results from three randomized, controlled clinical trials have consistently demonstrated the clinical benefits of Veklury. These data support the use of Veklury as a standard of care in hospitalized COVID-19 patients. The increased supply of Veklury will expand access to the medicine to additional appropriate patients with COVID-19, offering the potential for patients to recover faster and, in turn, increase healthcare provider capacity and reduce healthcare system costs.
Contact Information for
Hospitals interested in ordering Veklury beginning in October may contact AmerisourceBergen Specialty Division directly at 800-746-6273.
About Veklury (remdesivir)
Veklury (remdesivir) is a nucleotide analog invented by Gilead, building on more than a decade of the company’s antiviral research. Veklury has broad-spectrum antiviral activity both in vitro and in vivo in animal models against multiple emerging viral pathogens, including Ebola, SARS, Marburg, MERS and SARS-CoV-2, the virus that causes COVID-19. Data from three randomized, controlled clinical trials in hospitalized patients with COVID-19 have consistently demonstrated the clinical benefits of treatment with Veklury. In the placebo-controlled ACTT-1 study, Veklury significantly improved time to recovery and also reduced the likelihood of disease progression. Additional ongoing international Phase 3 clinical trials continue to evaluate the safety and efficacy of Veklury for the treatment of COVID-19, in different patient populations and formulations, and in combination with other therapies.
In recognition of the current public health emergency and based on available clinical data, the approval status of Veklury varies by country. To date, Veklury has been approved or authorized for temporary use as a COVID-19 treatment in approximately 50 countries worldwide.
Veklury has not been approved by the
For more information on Gilead’s response to the coronavirus outbreak please visit the company’s dedicated page: https://www.gilead.com/purpose/advancing-global-health/covid-19.
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. Veklury is an investigational drug that has not been approved by the FDA for any use, and it is not yet known if Veklury is safe or effective for the treatment of COVID-19. There is the possibility of unfavorable results from ongoing and additional clinical trials involving Veklury 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 Veklury or that FDA and other regulatory agencies may not approve Veklury, and any marketing approvals, if granted, may have significant limitations on its use. As a result, Veklury may never be successfully commercialized. In addition, there is also the risk that Gilead may be unable to effectively manage the global supply and distribution of Veklury. 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