Gilead Seeks Full US FDA Approval for Experimental Coronavirus Drug Remdesivir for Treatment of COVID-19

Gilead Sciences (Foster City, CA, USA) has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for remdesivir (Veklury), an investigational antiviral for the treatment of patients with COVID-19.

Remdesivir is being studied in multiple ongoing international clinical trials and has been approved by multiple regulatory authorities around the world, including in the European Union and Japan. Remdesivir has not been approved by the US FDA for any use but has been granted an Emergency Use Authorization (EUA) in the US for the treatment of hospitalized patients with severe COVID-19.

The filing is the final tier of the rolling NDA submission that was initiated on April 8, 2020. The filing is supported by data from two randomized, open-label, multi-center Phase 3 clinical studies of remdesivir conducted by Gilead and the Phase 3 randomized, placebo-controlled study of remdesivir conducted by the National Institute of Allergy and Infectious Diseases (NIAID). These studies demonstrated that treatment with remdesivir led to faster time to recovery compared with placebo and that a five-day or 10-day treatment duration led to similar clinical improvement. Across studies, remdesivir was generally well-tolerated in both the five-day and 10-day 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, 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. “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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