Gilead Submits New Drug Application to U.S. Food and Drug Administration for Veklury® (Remdesivir) for the Treatment of COVID-19
-- Veklury is Currently Available in the
The filing is supported by data from two randomized, open-label, multi-center Phase 3 clinical studies of Veklury conducted by Gilead and the Phase 3 randomized, placebo-controlled study of Veklury conducted by the
“Since the beginning of the pandemic, Gilead has worked with urgency to establish the efficacy and safety profile of Veklury, and we now have a robust data set supporting the evaluation of use of the drug across a range of hospitalized COVID-19 patient populations,” said
Veklury has been approved by multiple regulatory authorities around the world, including in the
Veklury (remdesivir) is an investigational 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 Veklury for the treatment of SARS-CoV-2 infection, the virus that causes COVID-19, in different patient populations, formulations, and in combination with other therapies.
Important Information about Veklury in
Veklury is an investigational drug that has not been approved by the FDA for any use, and the safety and efficacy of Veklury for the treatment of COVID-19 have not been established. 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
There are limited clinical data available for Veklury. Serious and unexpected adverse events may occur that have not been previously reported with Veklury use. Hypersensitivity reactions, including infusion-related and anaphylactic reactions, have been observed during and following administration of Veklury. The use of Veklury is contraindicated in patients with known hypersensitivity to remdesivir. Transaminase elevations have been observed in healthy volunteers and patients with COVID-19 in clinical trials who received Veklury. Patients should have appropriate clinical and laboratory monitoring to aid in early detection of any potential adverse events. Monitor renal and hepatic function prior to initiating and daily during therapy with Veklury; additionally monitor serum chemistries and hematology daily during therapy. Do not initiate Veklury in patients with ALT ≥5x ULN or with an eGFR <30 mL/min. The decision to continue or discontinue Veklury therapy after development of an adverse event should be made based on the clinical risk/benefit assessment for the individual patient.
Due to a risk of reduced antiviral activity, coadministration of Veklury and chloroquine phosphate or hydroxychloroquine sulfate is not recommended.
Healthcare providers and/or their designee are responsible for mandatory FDA MedWatch reporting of all medication errors and serious adverse events or deaths occurring during Veklury treatment and considered to be potentially attributable to Veklury. These events must be reported within 7 calendar days from the onset of the event. MedWatch adverse event reports can be submitted to FDA online at www.fda.gov/medwatch or by calling 1-800-FDA-1088.
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 (remdesivir) 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, Gilead may be unable to sufficiently scale up the production of Veklury in the currently anticipated timelines, and Gilead may be unable to meet future 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
For more information about the emergency use of Veklury (remdesivir) in
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