— If Granted by the European Commission, Veklury will Become the Only Direct-Acting Antiviral with Full Marketing Authorization in the EU —
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Commission (EC) adopted a positive opinion on the fulfillment of the last specific obligation and recommended the granting of Marketing Authorization (MA) for Veklury® (remdesivir) that is no longer subject to specific obligations. Veklury was initially granted a conditional marketing authorization in July 2020 for the treatment of COVID-19 in adults and adolescents (from 12 years of age and weighing at least 40 kilograms) with pneumonia requiring supplemental oxygen (low- or high-flow oxygen or other non-invasive ventilation at the start of treatment). In December of 2021, the conditional authorization was expanded to include adults who do not require supplemental oxygen and are at increased risk of developing severe COVID-19. The EC will review the CHMP recommendation and, pending adoption, Veklury will be fully authorized for these patients with COVID-19.
“We welcome the Committee’s positive opinion recommending a full marketing authorization for Veklury. Veklury continues to demonstrate durable activity against SARS-CoV-2 as it evolves, and it is the most used antiviral in hospitalized patients,” said Merdad Parsey, MD, PhD, Chief Medical Officer of Gilead. “More than two years into this pandemic, it’s critical to continue to secure access to effective treatments. We are proud of the role Veklury plays as the COVID-19 antiviral standard of care for hospitalized patients, and we remain committed to make it available to all patients that can benefit from it. We look forward to the EC’s decision.”
This positive opinion is based upon the fulfilment of the last specific obligation for Veklury, which included the review of virology data inclusive of in vitro data showing Veklury retains activity against variants of concern, including Alpha, Beta, Gamma, Delta and Omicron (BA.1 and BA.2). In addition, an assessment of the current risk-benefit of Veklury, which considered the efficacy and safety data accumulated since the initial granting of the conditional marketing authorization, was reviewed by the CHMP to support the change to a full marketing authorization.
In the European Economic Area (EEA), Veklury is the only antiviral indicated for both the treatment of COVID-19 in adult and adolescent patients with pneumonia requiring supplemental oxygen (low- or high-flow oxygen or other non-invasive ventilation) and adults who do not require supplemental oxygen and are at increased risk of developing severe COVID-19.
Veklury (remdesivir) is a nucleotide analog invented by Gilead, building on more than a decade of the company’s antiviral research. Veklury is a foundation for the treatment of hospitalized patients with COVID-19 and is a recommended treatment for reducing disease progression in non-hospitalized patients at high risk of disease progression. Veklury has an established safety profile and minimal drug interactions in diverse populations. It can help reduce disease progression across a spectrum of disease severity and enable patients to recover faster, freeing up limited hospital resources and saving healthcare systems money.
Veklury directly inhibits viral replication inside of the cell by targeting the SARS-CoV-2 viral RNA polymerase. Based on sequence analyses, Veklury should remain active against Omicron BA.4 and BA.5, as there are no new substitutions in the polymerase of BA.4 and BA.5. This suggests that Veklury will continue to be active against known Omicron variants. Gilead continuously evaluates the activity of Veklury against new SARS-CoV-2 variants of concern as they emerge around the world.
Veklury is approved in 50 countries worldwide. To date, Veklury and generic remdesivir have been made available to more than 11 million patients around the world, including more than 7 million people in 127 middle- and low-income countries through Gilead’s voluntary licensing program. These licenses currently remain royalty-free, reflecting Gilead’s existing commitment to enabling broad patient access to remdesivir.
About Gilead Sciences
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.