By Chris Wack


Gilead Sciences Inc. said Friday that European Commission regulators recommended the granting of marketing authorization for Veklury that is no longer subject to specific obligations.

The Committee for Medicinal Products for Human Use also adopted a positive opinion on the fulfillment of the last specific obligation for Veklury, or remdesivir, Gilead said, opening the way to its recommendation of full marketing authorization.

Veklury was initially granted a conditional marketing authorization in July 2020 for the treatment of Covid-19 in adults and adolescents with pneumonia requiring supplemental oxygen.

In December 2021, the conditional authorization was expanded to include adults who don't require supplemental oxygen and are at increased risk of developing severe Covid-19. The EC is expected to review the CHMP recommendation and, pending adoption, Veklury would be fully authorized for these patients with Covid-19.

Gilead said that in the European Economic Area, Veklury is the only antiviral indicated for both the treatment of Covid-19 in adult and adolescent patients with pneumonia requiring supplemental oxygen and adults who don't require supplemental oxygen and are at increased risk of developing severe Covid-19.


Write to Chris Wack at chris.wack@wsj.com


(END) Dow Jones Newswires

07-22-22 0739ET