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EU announces agreement with Gilead for remdesivir supply

Drug was granted conditional marketing authorisation in the EU in July

The European Commission (EC) has signed a joint procurement agreement (JPA) with the European Commission for Gilead’s COVID-19 antiviral treatment remdesivir.

Gilead's drug – sold under the Veklury brand name – was granted conditional approval by the EC in July for the treatment of COVID-19 patients with pneumonia requiring supplemental oxygen.

The approval was based on data from the ACCT-1 trial that demonstrated the clinical and safety of remdesivir in both five-day and ten-day dosing durations. Results showed that patients receiving remdesivir had a median recovery time of ten days compared to 15 days in the placebo group.

Gilead also published additional data from a comparative analysis of the phase 3 SIMPLE-Severe trial and a real-world respective cohort of patients with severe COVID-19 in July.

In this analysis, remdesivir demonstrated an improvement in clinical recovery and an impressive 62% reduction in the risk of death when compared to standard-of-care.

The new supply agreement enables countries in the EU, the European Economic Area (EEA) and the UK to purchase Gilead’s drug in real-time and for stockpiling needs. The deal covers purchases of remdesivir over the next six months and has the option to be extended beyond this, depending on demand – Gilead is set to begin fulfilling orders under the new deal next week.

The JPA replaces the initial deal funded by the EU’s emergency support instrument that ran from August through to October 2020. Both deals temporarily remove the need for country-by-country reimbursement processes in recognition of the current health crisis.

Gilead has scaled-up its production and manufacturing capabilities to meet the increasing demand following the positive results from the ACCT-1 trial and subsequent studies. The pharma giant said that it is on track to produce more than two million treatment course of remdesivir this year, and will produce several million more treatment course next year depending on demand.

Previously, countries across the EU have reported issues with procuring sufficient supplies of remdesivir after the US bought most of the global stock earlier this year.

The deal comes as COVID-19 cases continue to rise Europe, with cases rapidly increasing in a number of countries, including Belgium, France, Spain and the Netherlands.

In the UK, government data has shown that there were 17.540 new coronavirus cases recorded on Thursday, up from the 14,162 recorded the day before.

Experts have raised concerns that cases in the north of England, in particular, are spiralling out of control, with reports that the government are set to bring in new restrictions to help curb the spread in the worst affected areas.

9th October 2020

From: Research

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