Benzinga | Dec 21, 2021 04:34AM EST

Gilead Announced European Commission Expanded Indication for Veklury (Remdesivir) for the Treatment of Adults Not on Supplemental Oxygen and Considered High Risk for COVID-19 Disease Progression; Said Laboratory Findings Suggest Veklury Will Continue to Be Active vs Omicron Variant

Gilead Sciences, Inc. (NASDAQ:GILD) today announced that the European Commission (EC) has approved a variation to the Conditional Marketing Authorization for Veklury(r) (remdesivir) to include adults who do not require supplemental oxygen and are at an increased risk of progressing to severe COVID-19. This decision follows the positive recommendation of the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), to expand the indication for Veklury on December 16.

"As the rates of COVID-19 climb again and new variants like Omicron emerge, we need effective tools like Veklury to treat various stages of the disease," said Roger Paredes, MD, PhD, Chief Infectious Diseases Department, and IrsiCaixa AIDS Research Institute Hospital Universitari Germans Trias I Pujol Badalona, Spain. "We can now use Veklury to help prevent high-risk patients from progressing to more severe disease, even when they do not require oxygen, as well as continue to utilize Veklury as a key tool in the treatment of severe disease. This latest approval will also help to relieve some of the pressure on healthcare systems that are already under significant strain from the burden of COVID-19."

The EC's decision is supported by results from a Phase 3 randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of a three-day course of Veklury for intravenous (IV) use for the treatment of COVID-19 in non-hospitalized patients at high risk for disease progression. In an analysis of 562 participants randomly assigned in a 1:1 ratio to receive Veklury or placebo, Veklury demonstrated a statistically significant 87% reduction in risk for the composite primary endpoint of COVID-19 related hospitalization or all-cause death by Day 28 (0.7% [2/279]) compared with placebo (5.3% [15/283]) p=0.008. In the study, no deaths were observed in either arm by Day 28. The safety profile was similar between Veklury and placebo across the variety of outpatient settings in this trial, with the most common treatment emergent adverse events (5%) in patients taking Veklury being nausea and headache. These data have also been shared with other regulatory agencies around the world and submitted for scientific peer-reviewed publication.

This expanded indication in the EU adds to the previous Conditional Marketing Authorization of Veklury enabling the treatment of COVID-19 in adults and adolescents (aged 12 to less than 18 years and weighing at least 40 kg) with pneumonia requiring supplemental oxygen (low- or high-flow oxygen or other non-invasive ventilation at start of treatment).

"The swift action of the European Commission is a testament to the need for effective treatments that can be used earlier in the course of disease to help people with COVID-19 across Europe," said Merdad Parsey, M.D., Ph.D., Chief Medical Officer, Gilead Sciences. "As we learn more about how COVID-19 disease progresses, it is clear that an antiviral like Veklury can have a significant impact if used early in the course of disease. As the antiviral standard of care for patients hospitalized with COVID-19, we are proud of the role Veklury continues to play on the front lines of the pandemic, and we believe Veklury will now be able to help more patients decrease their time to recovery from COVID-19 in Europe."

In the United States, Veklury is indicated for adults and pediatric patients (12 years of age and older and weighing at least 40 kg) for the treatment of COVID-19 requiring hospitalization. The use of Veklury for the treatment of non-hospitalized patients with three days of dosing in the U.S. is investigational, and the safety and efficacy for this use and dosing duration have not been approved by the U.S. Food and Drug Administration (FDA). 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.

As new SARS-CoV-2 variants of concern emerge around the world, Gilead continuously evaluates the effectiveness of Veklury against viral variants. An initial analysis of genetic information from the Omicron variant suggests that Veklury will continue to be active against this variant. Gilead will conduct laboratory testing to confirm this analysis. To date, no major genetic changes have been identified in any of the known variants of concern that would significantly alter the viral RNA polymerase targeted by Veklury. Veklury's antiviral activity has been tested in vitro against isolates of variants of SARS-CoV-2, including Alpha, Beta, Gamma, Delta and Epsilon. These laboratory findings suggest that Veklury will continue to be active against the currently identified variations in the SARS-CoV-2 virus, including the Omicron variant.