Gilead’s Veklury received conditional marketing authorization from the European Commission
Updated: Jul 8, 2020
Gilead Sciences has announced that the European Commission has granted conditional marketing authorization for Veklury (remdesivir) for treating SARS-CoV-2 infection.
Veklury is indicated for adults and adolescents, with pneumonia and patients who require ventilation.
The drug is approved based on the global Phase 3 trial in patients who were hospitalized because of COVID-19 infection. The trial involved 1,063 hospitalized patients with COVID-19; 943 patients had severe disease among the patients enrolled. Patients who were on remdesivir recovered in 11 days compared to fifteen days in patients who were on placebo. In severe patients, time to recovery was 12 days for patients who were on remdesivir compared to 18 days for patients who were on placebo. No difference was observed in patients who had mild to moderate disease.
The drug is administered as an infusion into the view. The initiation dose is 200 mg infusion on day one, followed by 100 mg once a day for a minimum of five days and a maximum of ten days.
Remdesivir is a viral RNA polymerase inhibitor and inhibits the production of viral RNA, preventing viral replication. The drug has received approval in Japan, Taiwan, India, Singapore, the United Arab Emirates, and the European Union.
Gilead has to submit quality, effectiveness, safety by August 2020 to the European Commission.