FOSTER CITY, Calif.–(BUSINESS WIRE)–Oct. 1, 2020– Since the COVID-19 pandemic began, Gilead has worked diligently to ramp up production and rapidly expand the supply of our investigational antiviral drug Veklury® (remdesivir) by making significant investments to increase internal manufacturing capacity, expand our contract manufacturing network and implement process improvements. While working to increase our manufacturing capacity over these past months, the company also donated 1.5 million vials of Veklury and provided clinical drug supply at no cost for evaluation as an investigational agent in clinical trials around the world. As a result of the decision to make early investments to increase Veklury manufacturing efforts, Gilead is now meeting real-time demand for Veklury in the United States and anticipates meeting global demand for Veklury in October, even in the event of potential future surges of COVID-19.
Starting on October 1, Gilead will be responsible for distributing Veklury in the United States upon conclusion of the previous distribution agreement with the U.S. Federal government. To ensure stable management of drug supply in the near term, AmerisourceBergen will continue to serve as the sole U.S. distributor of Veklury through the end of this year and will sell the product directly to hospitals. This distribution model closely reflects the traditional model hospitals use to procure medicines. Hospitals will control the quantity of Veklury that they order, enabling them to have ample, predictable supply of Veklury in advance of any anticipated increase in COVID-19 incidence.
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 U.S. Veklury Orders
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 U.S. Food and Drug Administration (FDA) for any use, and its safety and efficacy have not been established. Gilead submitted a new drug application for Veklury on August 7, 2020; the NDA is currently under FDA review. Veklury is currently authorized for temporary use under an Emergency Use Authorization (EUA) for the treatment of hospitalized patients with COVID-19, including patients with moderate to severe disease, regardless of the need for supplemental oxygen. This authorization is temporary and may be revoked, and does not take the place of the formal new drug application submission, review and approval process. For information about the authorized use of Veklury and mandatory requirements of the EUA in the U.S., please review the Fact Sheets and FDA Letter of Authorization available at www.gilead.com/remdesivir.
About Gilead Sciences
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California.
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 June 30, 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.
Source: Gilead Sciences, Inc.
Posted: October 2020
- Gilead Submits New Drug Application to U.S. Food and Drug Administration for Veklury (remdesivir) for the Treatment of COVID-19 – August 10, 2020
Remdesivir FDA Approval History
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