Gilead Statement on Veklury® (Remdesivir) and the SARS-CoV-2 Omicron Variant

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Gilead has conducted an analysis of genetic information currently available for the Omicron variant and found no additional prevalent mutations in the viral RNA polymerase compared to previous SARS-CoV-2 variants. This suggests that Veklury® (remdesivir) will continue to be active against the Omicron variant and Gilead will conduct laboratory testing to confirm this analysis.

Veklury directly inhibits the SARS-CoV-2 replication inside infected cells by targeting the viral RNA polymerase. Initial genetic analysis of more than 200 available sequences of the Omicron variant isolates, including those from South Africa, Asia and Europe, has shown that no new mutations are present in the Omicron variant that are expected to alter the SARS-CoV-2 viral RNA polymerase compared to previous variants. This suggests that Veklury will continue to be active against the Omicron variant and Gilead will continue to analyze additional genetic sequences of the Omicron variant as they become available. Gilead conducts these analyses to ensure rapid and transparent updates on the potential effectiveness of Veklury.

In addition to genetic analyses, Gilead continues to experimentally evaluate the activity of Veklury against identified SARS-CoV-2 variants through in vitro antiviral testing. Veklury’s antiviral activity has been confirmed in vitro against all major previously identified variants of SARS-CoV-2 including Alpha, Beta, Gamma, Delta, and Epsilon. Due to the similarities in the viral RNA polymerase, these laboratory findings suggest that Veklury will also continue to be active against the Omicron variant and Gilead will conduct laboratory testing to confirm this analysis.

Gilead is working with experts in governments and academia to obtain viral isolates and conduct in vitro laboratory testing of Veklury’s antiviral activity against the Omicron variant, which requires additional time. As soon as the testing is complete, Gilead will share the data with regulatory agencies, treating physicians and public health authorities.

To date, no major genetic changes have been identified in any of the known SARS-CoV-2 variants of concern and variants of interest that would significantly alter the viral RNA polymerase targeted by Veklury. In contrast, all identified variants show mutations at different locations in the SARS-CoV-2 spike protein, which is on the outer surface of the virus and serves as a target for all neutralizing anti-SARS-CoV-2 antibodies.

Veklury is approved or authorized for temporary use in approximately 50 countries worldwide. Veklury and generic remdesivir have been made available to nine million patients around the world, including 6.5 million people in 127 middle- and low-income countries through our voluntary licensing program.

Veklury is the antiviral standard of care for the treatment of people hospitalized with COVID-19. It can help reduce disease progression across the spectrum of disease severity and enable hospitalized patients to recover faster, freeing up limited hospital resources and saving healthcare systems money. Veklury is contraindicated in patients who are allergic to Veklury or any of its components; please see below for additional Important Safety Information for Veklury.

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