EMA’s human medicines committee (CHMP) has recommended granting a conditional marketing authorisation to Veklury (remdesivir) for the treatment of COVID-19 in adults and adolescents from 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.
Study NIAID-ACTT-1 evaluated the effectiveness of a planned 10-day course of remdesivir in over 1,000 hospitalised patients with COVID-19. Remdesivir was compared with placebo (a dummy treatment) and the main measure of effectiveness was patients’ time to recovery (defined as no longer being hospitalised and/or requiring home oxygen or being hospitalised but not requiring supplemental oxygen and no longer requiring ongoing medical care).
Overall, the study showed that patients treated with remdesivir recovered after about 11 days, compared with 15 days for patients given placebo. This effect was not observed in patients with mild to moderate disease: time to recovery was 5 days for both the remdesivir group and the placebo group.
For patients with severe disease, who constituted approximately 90% of the study population, time to recovery was 12 days in the remdesivir group and 18 days in the placebo group.
However, no difference was seen in time to recovery in patients who started remdesivir when they were already on mechanical ventilation or ECMO (extracorporeal membrane oxygenation).