Gilead Submits New Drug Application to FDA for Remdesivir (Veklury) as a Treatment for COVID-19

Today, Gilead Sciences announced that it has submitted a New Drug Application (NDA) to the U.S. FDA for Veklury (remdesivir), an investigational antiviral drug for the treatment of patients with COVID-19. Veklury is currently authorized under Emergency Use Authorization (EUA) in the United States for the treatment of hospitalized patients with severe COVID-19.

Remdesivir is an investigational nucleotide analog with broad-spectrum antiviral activity in vitro and in animal models in vivo, effective against multiple emerging viral pathogens. Several ongoing international Phase 3 clinical trials are evaluating its safety and efficacy for the treatment of SARS-CoV-2 infection causing COVID-19 across diverse patient populations, formulations, and in combination with other therapies. It has been approved by multiple regulatory authorities worldwide, including those in the European Union and Japan.

This application is supported by data from two randomized, open-label, multicenter Phase 3 clinical trials conducted by Gilead Sciences, Inc., and a randomized, placebo-controlled Phase 3 study conducted by the National Institute of Allergy and Infectious Diseases (NIAID). These studies demonstrated that, compared with placebo, remdesivir treatment resulted in faster recovery times, and that 5-day or 10-day treatment courses provided similar clinical improvements.

▲Molecular structure of remdesivir (Image source: Hbf878 / CC0)

“Since the start of the pandemic, Gilead Sciences has been working with the utmost urgency to determine the efficacy and safety of remdesivir. We now have a robust dataset supporting the use of this drug in a range of hospitalized COVID-19 patient populations,” said Dr. Merdad Parsey, Chief Medical Officer of Gilead Sciences. “Today’s application marks an important milestone, and we will continue to collaborate with healthcare institutions around the world to address the treatment needs of patients with COVID-19.”

References:

[1] Gilead Submits New Drug Application to U.S. Food and Drug Administration for Veklury® (Remdesivir) for the Treatment of COVID-19. Retrieved August 10, 2020, from https://www.businesswire.com/news/home/20200810005486/en

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