Gilead has signed a joint procurement agreement with the European Commission (EC) to enable ‘rapid and equitable’ access to its COVID-19 antiviral remdesivir, sold under the brand name Veklury.
This new agreement allows participating countries in the EU, the European Economic Area (EEA) and the UK to purchase Gilead’s drug for both real-time demand and stockpiling needs.
It covers purchases of remdesivir over the next six months with the option to be extended beyond this. This agreement replaces the initial emergency support instrument that enable the EC to procure remdesivir for EU member states – including the UK – that ran from August through to October 2020.
Both agreements removed the need for country-by-country reimbursement processes that usually follow marketing authorisation, given the urgency of the pandemic.
The EC granted remdesivir conditional marketing authorisation back in July, based on data from the ACTT-1 trial that demonstrated clinical efficacy and safety of the drug in COVID-19 patients with pneumonia requiring supplemental oxygen.
The authorisation was also supported by data from two randomised clinical trials demonstrating the efficacy and safety of remdesivir in five-day and ten-day dosing durations.
The antiviral also improved clinical outcomes across a broad range of assessments, including significantly improving time to recovery and also reducing the likelihood of disease progression compared to placebo.
Additional ongoing phase III studies continue to evaluate the efficacy and safety of remdesivir for the treatment of COVID-19, in different patient populations and formulations and in combination with other therapies.