European Commission Expands Veklury (Remdesivir) Indication to Include High-Risk, Non-Hospitalized COVID-19 Adults Not Requiring Oxygen
Dec 22, 2021 23:39
CST Updated
23:39
Gilead Sciences
Antiviral Drug Developer
European Commission
The European Commission, abbreviated as the EU Commission, is a supranational body under the European Union. Within the EU political system, the European Commission primarily undertakes executive tasks, thus being roughly equivalent to the government in a national system. However, the European Commission has other functions as well. In particular, except for the few circumstances specified in the treaties, the European Commission is the only institution with legislative power in the EU legislative process.
December 21, 2021 /BioValleyBIOON/ -- Gilead Sciences recently announced that the European Commission (EC) has approved the expanded indication for the antiviral drug Veklury (remdesivir):Include adult patients who do not require oxygen supplementation and are at increased risk of developing severe COVID-19.Previously, Veklury received conditional approval in the EU for the treatment of adults and adolescents (aged ≥12 years, weighing ≥40 kg) with COVID-19 who require supplemental oxygen and have pneumonia.
Roger Paredes, Head of the Infectious Diseases Department at the Germans Trias i Pujol University Hospital in Badalona, Spain, stated: "With the resurgence of COVID-19 and the emergence of new variants like Omicron, we need effective tools like Veklury to treat all stages of the disease. We can now use Veklury to help prevent high-risk patients from progressing to more severe illness, and even when they do not require supplemental oxygen, Veklury can continue to be a key treatment for severe cases. This latest approval will also help alleviate some of the pressure on healthcare systems that are already heavily burdened by the pandemic."
This EU approval is based on results from a Phase 3 randomized, double-blind, placebo-controlled trial. The trial was conducted in non-hospitalized COVID-19 patients at high risk of disease progression and evaluated the efficacy and safety of a 3-day course of Veklury administered intravenously (IV). A total of 562 patients were randomized 1:1 to receive either Veklury or placebo.
Results show:By Day 28, compared with placebo, Veklury significantly reduced the risk of the composite endpoint of COVID-19-related hospitalization or all-cause death by 87% (0.7% [2/279] vs 5.3% [15/283], p=0.008).。In this study, no deaths were observed in either group by Day 28. The safety of Veklury and placebo was similar across various outpatient settings in the study. The most common treatment-emergent adverse events (≥5%) in patients receiving Veklury were nausea and headache.
Gilead Chief Medical Officer Merdad Parsey, M.D., stated: "The rapid action by the European Commission underscores the need for effective treatments that can be used early in the disease to help patients with COVID-19 across Europe. As we learn more about the progression of COVID-19, it is clear that antiviral medicines like Veklury can have a significant impact when used earlier in the disease. As the standard of antiviral treatment for patients with COVID-19, we are proud that Veklury continues to play a role on the front lines of the pandemic, and we believe Veklury is now able to help more patients recover from COVID-19 sooner."
Remdesivir - Chemical Structure of Remdesivir
Veklury is an antiviral drug developed by Gilead Sciences that inhibits the replication of SARS-CoV-2, the virus that causes COVID-19. In the United States, Veklury has been approved to treat pediatric and adult patients aged 12 years and older, weighing at least 40 kilograms, who require hospitalization for COVID-19.
As new SARS-CoV-2 variants emerge around the world, Gilead is continuously evaluating the effectiveness of Veklury against viral variants. Preliminary analysis of genetic information from the Omicron variant suggests that Veklury will continue to be effective against this variant. Gilead will conduct laboratory tests to confirm the analysis. To date, no significant issues have been identified in any known variants.GeneticsChanges would significantly alter Veklury's targeting of the viral RNA polymerase. The antiviral activity of Veklury has been tested in vitro against SARS-CoV-2 variants, including α, β, γ, δ, and ε. These laboratory study results indicate that Veklury will continue to effectively combat currently identified SARS-CoV-2 viral variants, including the Omicron variant. (Bioon.com)