Gilead Submits NDA to FDA for Remdesivir to Treat COVID-19

On Aug. 10, 2020, Gilead Sciences announced that it has submitted a new drug application (NDA) to FDA for Veklury (remdesivir), an investigational antiviral for treating patients with COVID-19. The company said in a press release that the drug is currently available in the United States under an Emergency Use Authorization granted by FDA for treating hospitalized patients with severe COVID-19. This current filing is the final tier of a rolling NDA submission that Gilead initiated on April 8, 2020.

The current filing is based on data from two Phase III clinical studies conducted by Gilead and another Phase III study conducted by the National Institute of Allergy and Infectious Diseases (NIAID). These studies showed that Veklury led to a faster recovery time compared with placebo and that treatment with the drug for five days or 10 days led to similar clinical improvement. The drug was shown to be generally well-tolerated in both the five-day and 10-day treatment groups, according to Roche in the press release.

“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, MD, PhD, chief medical officer, Gilead Sciences, in the press release. “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.”

Veklury is approved for use in other countries, including in the European Union and Japan.

Source: Gilead Sciences