European Commission Grants Conditional Marketing Authorization for Gilead’s Veklury® (remdesivir) for the Treatment of COVID-19
-- Veklury is the First Approved Treatment Option for COVID-19 in the
Under this authorization, Veklury is indicated for the treatment of COVID-19 in adults and adolescents (aged 12 years and older and weighing at least 40 kg), with pneumonia requiring supplemental oxygen.
“We appreciate the European Medicines Agency’s rapid review of remdesivir in recognition of the unprecedented nature of this pandemic,” said
Veklury has been studied in hospitalized COVID-19 patients spanning a range of disease severity. The conditional marketing authorization for Veklury is supported by the
Ongoing clinical trials continue to evaluate the safety and efficacy of remdesivir, including studies of remdesivir in combination with anti-inflammatory medicines and in special populations including pediatric patients. Research is also being conducted on new, investigational formulations of remdesivir that may enable studies of remdesivir in earlier stages of disease.
Veklury (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. In recognition of the current public health emergency and based on available clinical data, remdesivir has been approved as a treatment for patients with severe COVID-19 in
Important Information about Remdesivir in
Remdesivir is an investigational drug that has not been approved by the FDA for any use, and the safety and efficacy of remdesivir for the treatment of COVID-19 have not been established. This authorization is temporary and may be revoked, and it 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
There are limited clinical data available for remdesivir. Serious and unexpected adverse events may occur that have not been previously reported with remdesivir use. Hypersensitivity reactions, including infusion-related and anaphylactic reactions, have been observed during and following administration of remdesivir. The use of remdesivir 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 remdesivir. 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 remdesivir; additionally monitor serum chemistries and hematology daily during therapy. Do not initiate remdesivir in patients with ALT ≥5x ULN or with an eGFR <30 mL/min. The decision to continue or discontinue remdesivir 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 remdesivir 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 remdesivir treatment and considered to be potentially attributable to remdesivir. 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.
Gilead Forward-Looking Statement
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, including the risk that the
Veklury, Gilead and the Gilead logo are trademarks of
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Sarah Swift, Media –
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