Gilead Sciences (Gilead) has announced the Committee for Medicinal Products for Human Use (CHMP) of the European Commission (EC) has adopted a positive opinion of Veklury (remdesivir), recommending the COVID-19 treatment receive full marketing authorisation.
Veklury was granted a conditional marketing authorisation in July 2020 for adult and paediatric patients 12 years of age and older and weighing at least 40kg for the treatment of COVID-19 requiring supplemental oxygen. The conditional authorisation was expanded in December 2021 to include high-risk adults not requiring supplemental oxygen.
If approvd by the EC, Veklury will become the only direct-acting antiviral with full marketing authorisation in the European Union.
The positive opinion is supported by the fulfilment of the last specific obligation for Veklury, including the review of virology data inclusive of in vitro data demonstrating the treatment retains activity against variants of concern. The CHMP also reviewed an assessment of the current risk-benefit of Veklury considering the efficacy and safety data accumulated since the initial granting of the conditional MA.
Commenting on the positive opinion, Merdad Parsey, chief medical officer of Gilead, said:
“More than two years into this pandemic, it’s critical to continue to secure access to effective treatments. Veklury continues to demonstrate durable activity against SARS-CoV-2 as it evolves, and it is the most used antiviral in hospitalised patients.
“We welcome the Committee’s positive opinion recommending a full marketing authorisation for Veklury.”
Veklury directly inhibits viral replication in cells by targeting the SARS-CoV-2 viral RNA polymerase. Based on sequence analyses, the treatment should remain active against Omicron BA.4 and BA.5 as there are no new substitutions in the polymerase of BA.4 and BA.5, the company said, suggesting that Veklury will continue to be active against known Omicron variants.
In April 2022, Gilead announced updates to the World Health Organization’s (WHO) Therapeutics and COVID-19 living guidelines, which now conditionally recommends Veklury for use in the treatment of patients with non-severe COVID-19 deemed to be at the highest risk of hospitalisation.
The revised recommendation was based on positive results from a phase 3 trial demonstrating that a three-day course of the treatments ‘significantly reduced’ the risk of hospitalisation for non-hospitalised patients at high risk of disease progression.