The European Commission (EC), the executive branch of the European Union that manages the bloc's day-to-day business, has given conditional approval for the antiviral remdesivir to be used in treating severe cases of COVID-19. Remdesivir is being sold under the brand name "Veklury."
The antiviral made by U.S. firm Gilead Sciences Inc. will be used in adults and adolescents from 12 years of age and weighing at least 40 kg also suffering from pneumonia and requiring oxygen support. The EC said it's negotiating with Gilead Sciences to obtain doses of remdesivir for all 27 EU member states. The U.S. has secured 500,000 treatment courses of remdesivir, practically wiping-out the available supply.
Demand for remdesivir worldwide is huge. A number of clinical studies have shown the intravenously-administered antiviral helped shorten hospital recovery times by about a third. Remdesivir is believed to be most effective in treating COVID-19 patients earlier in the course of disease than other therapies.
A conditional marketing authorization in the EU is initially valid for one year. It can be extended or converted into an unconditional marketing authorization after the submission and assessment of additional confirmatory data.
Remdesivir is the only anti-COVID-19 drug to be given the go ahead in the EU. It also holds the same distinction in the United States. On May 1, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for remdesivir to treat suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease.
The EC approval after an accelerated review process follows the European Medicines Agency (EMA) last week recommending remdesivir be approved for treating patients requiring supplemental oxygen.
Dr. Merdad Parsey, PhD, Chief Medical Officer, Gilead Sciences, said the company appreciates the EMA's rapid review of remdesivir in recognition of the unprecedented nature of this pandemic. He said the conditional marketing authorization is an important step forward as both Gilead Sciences and the EU work together to address the treatment needs of patients across Europe.
Remdesivir has now been cleared for emergency use, and approved as a COVID-19 therapy in the EU, the U.S., Japan, Taiwan, India, Singapore and the United Arab Emirates.
The conditional marketing authorization is supported by the U.S. National Institute of Allergy and Infectious Diseases' (NIAID) global Phase 3 trial of remdesivir. A number of ongoing clinical trials continue to evaluate the safety and efficacy of remdesivir. Research is also being conducted on new, investigational formulations of remdesivir that might enable studies of remdesivir in earlier stages of disease.
