The New Drug Application (NDA) for remdesivir (Veklury®; Gilead Sciences) has been submitted to the Food and Drug Administration (FDA) for the treatment of patients with coronavirus disease 2019 (COVID-19).

Remdesivir is an investigational nucleotide analogue with broad-spectrum antiviral activity. It is currently available in the US under an 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 rolling NDA submission was initiated on April 8, 2020.

The application is supported by data from 2 randomized, open-label, multicenter phase 3 clinical studies (NCT04292730 and NCT04292899) conducted by Gilead and a randomized, placebo-controlled, phase 3 study (NCT04280705) conducted by the National Institute of Allergy and Infectious Diseases (NIAID). The studies evaluated the efficacy and safety of remdesivir in hospitalized patients with COVID-19. Patients were administered 200mg of remdesivir intravenously on the first day, followed by 100mg daily thereafter for 5 or 10 days.

Results from these studies showed a faster time to recovery in patients treated with remdesivir compared with placebo. Moreover, the studies demonstrated similar clinical improvement with the 5-day and 10-day treatment regimens. As for safety, remdesivir was found to be well tolerated with no new safety signals identified.

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“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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Gilead submits New Drug Application to US Food and Drug Administration for Veklury® (remdesivir) for the treatment of COVID-19. Accessed August 10, 2020.