The European Medicines Agency (EMA) has recommended granting conditional marketing authorisation to Veklury (remdesivir) for the treatment of COVID-19 in patients ≥12 years of age with pneumonia, who require supplemental oxygen.
Remdesivir is the first medicine against COVID-19 to be recommended for authorisation in the EU. Treatment starts with a single 200 mg infusion, followed by one 100 mg infusion daily for at least four days and no more than nine days.
The recommendation is mainly based on data from the NIAID-ACTT-1 study, plus supporting data from other studies.
NIAID-ACTT-1 evaluated the efficacy of remdesivir compared to placebo, the primary outcome measure was patients’ time to recovery. In patients with severe disease, approximately 90% of the study population, time to recovery was 12 days and 18 days in the remdesivir and placebo groups, respectively. However, no difference was seen in patients who started remdesivir when they were already on mechanical ventilation or ECMO (extracorporeal membrane oxygenation), or in patients with mild to moderate disease.
Further mortality data are being collected and efficacy and safety data will be collected through on-going studies.