Gilead Sciences and the European Commission signed a new joint procurement agreement (JPA) that will ensure continued rapid and equitable access to Veklury (remdesivir) for participating Member States across the European Union (EU) and European Economic Area (EEA).
The agreement covers purchases of Veklury over the next twelve months and has the option to be extended for an additional six months. It follows the expiration of the original JPA agreement, the first for a COVID-19 therapeutic, signed in October 2020.
“We welcome this new JPA for Veklury which will continue to help governments across Europe ensure they have rapid access to this critical treatment,” said Johanna Mercier, Chief Commercial Officer, Gilead Sciences. “Veklury is the antiviral standard-of-care treatment for appropriate hospitalized patients across a spectrum of COVID-19 disease severity. It has helped hundreds of thousands of patients across Europe recover faster and reduce hospital stays, which generate savings for healthcare systems. Following the recent expanded indication to patients at risk for disease progression, Veklury now has the potential to help even more patients so we are pleased this JPA will help ensure Veklury is available for patients when they need it.”
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.