Europe Expands Indication for Use of Veklury (Remdesivir)

California-based Gilead Sciences, Inc. today announced that the European Commission (EC) had approved a variation to the Conditional Marketing Authorization for Veklury® (remdesivir) to include adults who do not require supplemental oxygen and are at an increased risk of progressing to severe 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 use for the treatment of COVID-19 in non-hospitalized patients at high risk for disease progression. 

"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, Ph.D., Chief Infectious Diseases Department, and IrsiCaixa AIDS Research Institute Hospital Universitari Germans Trias I Pujol Badalona, Spain, in a press statement issued on December 21, 2021.

"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."

This expanded indication in Europe 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).

Veklury is approved or authorized for temporary use in approximately 50 countries worldwide.

To date, Veklury and generic remdesivir have been made available to nine million patients worldwide, including 6.5 million people in 127 middle- and low-income countries through Gilead's voluntary licensing program. 

In the United States, Veklury (remdesivir 100 mg for injection) is indicated for certain adults and pediatric patients.

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.