Gilead is seeking full approval for its investigational COVID-19 drug remdesivir in the US, after filing an application with the US Food and Drug Administration (FDA).
The FDA has already granted the drug an emergency use authorisation (EUA) after the drug helped reduced hospital recovery time in a US trial.
The US application is based on two late-stage trials conducted by Gilead and another by the National Institute of Allergy and Infectious Diseases (NIAID).
These studies found that treatment with remdesivir led to faster time to recovery compared with placebo, and that a five-day or ten-day treatment duration caused similar levels of clinical improvement.
Across the studies, remdesivir was generally well-tolerated in both treatment groups, with no new safety signal identified.
Remdesivir has already been approved by multiple regulatory authorities with the brand name Veklury, including in the European Union and Japan.
“Since the beginning of the pandemic, Gilead has worked with urgency to establish the efficacy and safety profile of Veklury, and we now have a robust data set supporting the evaluation of use of the drug across a range of hospitalized COVID-19 patient populations,” said Merdad Parsey, Chief Medical Officer at Gilead Sciences.
“Today’s filing is an important milestone as we continue to partner with the US government and healthcare authorities around the globe to address the treatment needs of patients with COVID-19,” he added.
