CHMP adopts a positive opinion, recommending a change to marketing authorisation for Veklury (remdesivir)

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for Veklury. The CHMP adopted an extension to an existing indication to include treatment of children of at least 4 weeks of age and weighing at least 3 kg who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19. The indication for Veklury will therefore be as follows:

Veklury is indicated for the treatment of coronavirus disease 2019 (Covid‑19) in adults and paediatric patients (at least 4 weeks of age and weighing at least 3 kg): with pneumonia requiring supplemental oxygen (low- or high-flow oxygen or other non-invasive ventilation at start of treatment) ) • )who do not require supplemental oxygen and who are at increased risk of progressing to severe Covid-19. Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.