First COVID-19 treatment recommended for EU authorization | CDE Almería - Centro de Documentación Europea

EMA’s human medicines committee (CHMP) has recommended granting 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. Data on remdesivir were assessed in an exceptionally short timeframe through a rolling review procedure, an approach used by EMA during public health emergencies to assess data as they become available. From 30 April 2020, the CHMP began assessing data on quality and manufacturing, non-clinical data, preliminary clinical data and supporting safety data from compassionate use programmes, well in advance of the submission of the marketing authorisation application on 5 June

The assessment of the dossier has now concluded with today’s recommendation, which is mainly based on data from study NIAID-ACTT-1, sponsored by the US National Institute of Allergy and Infectious Diseases (NIAID), plus supporting data from other studies on remdesivir

Taking into consideration the available data, the Agency considered that the balance of benefits and risks had been shown to be positive in patients with pneumonia requiring supplemental oxygen; i.e., the patients with severe disease. Remdesivir is given by infusion (drip) into a vein and its use is limited to healthcare facilities in which patients can be monitored closely; liver and kidney function should be monitored before and during treatment, as appropriate. Treatment should start with a 200-mg infusion on the first day, followed by one 100-mg infusion a day for at least 4 days and no more than 9 days