Gilead COVID-19 drug Veklury gets EMA panel nod for full approval in EU
humonia


A committee of the European Medicines Agency (EMA) recommended granting full marketing authorization to Gilead Sciences (NASDAQ:GILD) Veklury (remdesivir) to treat patients with COVID-19.
July 2020 Veklury was granted conditional marketing authorization to treat COVID-19 in patients 12 years of age and above, weighing at least 40 kilograms, with pneumonia requiring supplemental oxygen (low- or high-flow oxygen or other non-invasive ventilation at the start of treatment). In December 2021, authorization was expanded to include adults who do not require supplemental oxygen and are at increased risk of developing severe COVID-19.

Gilead said the positive opinion by the EMA's Committee for Medicinal Products for Human Use was based on fulfilment of the last specific obligation for Veklury, which included the review of virology data inclusive of in vitro data showing that the drug retained activity against variants, including Alpha, Beta, Gamma, Delta and Omicron (BA.1 and BA.2).
The European Commission (EC) will make a final decision, which generally follows the recommendation of the EMA, whether to approve the drug.
GILD +0.18% to $61.12 premarket July 22