
Gilead Sciences signed joint procurement agreement with the European Commission for Veklury (Remdesivir)
On Jul. 19, 2022, Gilead Sciences and the European Commission announced a new joint procurement agreement (JPA) that ensured continued rapid and equitable access to Veklury (remdesivir) for participating Member States across the European Union (EU) and European Economic Area.
The agreement covers purchases of Veklury over the next twelve months and had the option to be extended for an additional six months. It followed the expiration of the original JPA agreement, the first for a COVID-19 therapeutic, signed in October 2020.
In the EU and EEA Veklury is the only antiviral indicated for 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). In December 2021, the European Commission expanded the indication for Veklury to include adults who do not require supplemental oxygen and are at an increased risk of progressing to severe COVID-19.
The expanded European conditional marketing authorization was 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 the treatment of COVID-19 in patients at high risk for disease progression. In this study, 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, there were no deaths in either arm through the primary endpoint. The study was also the basis for the World Health Organization’s updated Therapeutics and COVID-19 living guideline, which now conditionally recommends Veklury for use in patients with non-severe COVID-19 at the highest risk of hospitalization.
Veklury (remdesivir) is a nucleotide analog invented by Gilead, building on more than a decade of the company’s antiviral research. Veklury is the antiviral standard of care 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 broad spectrum of disease severity and enable patients to recover faster, freeing up limited hospital resources and generating savings to healthcare system
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Source: Gilead
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