Remdesivir New Drug Application Submitted to FDA

August 12, 2020

The investigational antiviral remdesivir in phase 3 clinical trials led to faster time to recovery vs placebo and was found to be safe.

A new drug application (NDA) for remdesivir was submitted today to the US Food and Drug Administration (FDA). Remdesivir is an investigational antiviral agent for the treatment of patients with coronavirus 2019 (COVID-19) infection.

The nucleotide analog with broad-spectrum antiviral activity is currently available in the US under an FDA Emergency Use Authorization (EUA) for patients with suspected or laboratory-confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and severe COVID-19. The submission is the final step in the rolling NDA submission imitated on April 8, 2020.

Today’s submission is supported by data from 3 studies: 2 randomized, open-label, multicenter phase 3 clinical studies conducted by Gilead Sciences, Inc, and a randomized, placebo-controlled, phase 3 study conducted by the National Institute of Allergy and Infectious Diseases. The studies evaluated the efficacy and safety of remdesivir in hospitalized patients with COVID-19. Patients were administered 200 mg of remdesivir intravenously on the first day, followed by 100 mg daily thereafter for 5 or 10 days.

Compared with placebo, time to recovery among patients treated with remdesivir was faster than for those who received placebo. The studies found also that clinical improvement was similar with the 5-day and 10-day treatment regimens. Remdesivir was well tolerated in both treatment groups with no new safety signals identified.

“Since the beginning of the pandemic, Gilead has worked with urgency to establish the efficacy and safety profile of Veklury [remdesivir] , 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 a company 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.”

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