Dubai: Gilead Sciences, Inc. (Nasdaq: GILD) announced that the United Arab Emirates’ Ministry of Health and Prevention has granted regulatory approval of Veklury® (remdesivir) as an Emergency Medicine for treatment of SARS-CoV-2 infection, the virus that causes COVID-19.
The regulatory approval is supported by clinical data from the U.S. National Institute of Allergy & Infectious Diseases’ global Phase 3 trial, Gilead’s Phase 3 SIMPLE trial in patients with severe manifestations of COVID-19, and Remdesivir Compassionate Use Data, demonstrating the benefit of this treatment in helping patients recover faster, while having a trend towards a mortality benefit.
Gilead understands the urgent needs of patients around the world, and the company has proactively scaled up manufacturing of remdesivir to increase available supply, as rapidly as possible. While there is currently limited global supply of remdesivir, the company anticipates new supply of the drug to start to become available in July, with supply continuing to increase through the end of this year and into next year. Gilead will work closely with the health authorities in UAE to provide guidance on anticipated drug supply based on local incidence and severity of disease.
About Remdesivir
Remdesivir is a nucleotide analog with broad-spectrum antiviral activity both in vitro and in vivo in animal models against multiple emerging viral pathogens. Multiple ongoing international Phase 3 clinical trials are evaluating the safety and efficacy of remdesivir for the treatment of SARS-CoV-2, the virus that causes COVID-19. The approval status of remdesivir varies by country. In countries where remdesivir has not been approved by the regional health authority, remdesivir is an investigational drug, and the safety and efficacy of remdesivir has not been established. In the U.S., the U.S. Food and Drug Administration (FDA) granted remdesivir an Emergency Use Authorization (EUA) for the treatment of hospitalized patients with severe COVID-19; 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 remdesivir and mandatory requirements of the EUA 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 has not been demonstrated to be safe and 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 is unable to sufficiently scale up manufacturing 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 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.
© Press Release 2020
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