The European Commission (EC) has signed a joint procurement contract (from the EC’s Emergency Support Instrument (ESI), worth a total of EUR 70 million) with pharma giant Gilead, with the opportunity to extend the supply beyond the initial 500,000-treatment level if necessary. Participating countries now can place orders to procure the drug directly with the company.
Stella Kyriakides, EC commissioner for health and food safety, said, “We are leaving no stone unturned in our efforts to ensure that safe and efficient therapeutics are available against COVID-19. Through our EU Joint Procurements, we are empowering countries across Europe to join forces and get access to vital equipment and medicines. We are always stronger together, and this is European solidarity in action against COVID-19.”
EC press officer for health and food safety Darragh Cassidy told Outsourcing-Pharma the European Medicines Agency (EMA) started assessing remdesivir data at the end of April, in anticipation of the marketing authorization application, submitted on June 8, covering data on quality and manufacturing, preliminary data from clinical studies, and supporting data from compassionate-use programs.
“Following the EMA favorable assessment, the EC granted a conditional marketing authorization for the remdesivir-containing medicine Veklury for the treatment of COVID-19 in adults and adolescents from 12 years of age with pneumonia who require supplemental oxygen,” Cassidy related.
According to the EC, the courses purchased with ESI funding to date have helped meet immediate needs from August until October to ensure that critical patient treatments, with medication disbursed in several installments. Cassidy told OSP the EC will continue to monitor developments related to the COVID-19 pandemic in Europe and across the globe.
“Should needs arise, we will endeavor to mobilize any means and instrument necessary to continue to assure the protection of public health,” he said.