Gilead Sciences, Inc. has applied for U.S. Food and Drug Administration approval for remdesivir, its experimental COVID-19 drug currently being used under emergency authorization, the company said Monday.
Gilead Sciences hopes to get full FDA approval for its potential broad-spectrum antiviral vaccine after submitting a new drug application, or NDA, Monday.
Health authorities have given Gilead's candidate drug authorization for emergency use, the American biopharmaceutical company said. Remdesivir has shortened COVID-19 patients' hospital recovery time during a U.S. test and has been used to contain the virus since being granted emergency authorization in May.
Gilead said its FDA filing was the last step in its NDA submissions it commenced April 8. The candidate vaccine will be marketed and sold as Veklury. Remdesivir is a RNA polymerase inhibitor - which means it can disrupt the growth of viral genetic material and stop diseases from attacking cells.
The company made sure Veklury is safe and effective, Gilead's chief medical officer Merdad Parsey said. Parsey said Gilead had a strong collection of data critical in the application of its potential vaccine across a broad spectrum of hospitalized COVID-19 patients.
The filing is a crucial achievement, Parsey said in a statement. The company continues to collaborate with U.S. health experts and other international authorities to address the medical requirements of COVID-19 patients.
Two months ago Gilead released encouraging results in a phase-3 clinical test of remdesivir in partnership with the National Institute of Allergy and Infectious Diseases.
The European Union, Japan and Australia, among others, have approved the use of remdesivir.
