Regulators endorse remdesivir in further boost to company, which has seen shares soar 17% this year
Doctors in Europe will soon be able to treat COVID-19 patients with Gilead's antiviral drug, remdesivir, after regulators put it on track to become the first therapy for the disease on the continent, according to a Reuters report.
The European Medicines Agency (EMA) said its human medicines committee (CHMP) recommended conditionally approving the drug for adults and adolescents from 12 years of age, who are also suffering from pneumonia and require oxygen support.
EU conditional marketing authorisation allows a treatment to be sold for a year in the 27-nation bloc before all necessary data on its efficacy and side-effects are available. Gilead has until December to submit this data.
The endorsement means physicians can prescribe the Gilead drug in Europe once the European Commission, the EU executive, gives its approval, which is expected over the coming week.
U.S.-based Gilead, whose shares have risen 17% this year, said it has not yet set a price. Demand for the drug soared after COVID-19 trials showed promise, but supply could be an issue.
Remdesivir is designed to hinder certain viruses, including the new coronavirus, from making copies of themselves and potentially overwhelming the body's immune system. The drug previously failed trials as an Ebola treatment.