Gilead has submitted a New Drug Application (NDA) for Veklury (remdesivir) to the Food and Drug Administration (FDA) for treating patients with COVID-19. The drug has already received Emergency Use Authorization for treatment of hospitalized patients with severe COVID-19.
The application has been supported by the two randomized, open-label, multi-center Phase 3 trials. The trial has been conducted by the National Institute of Allergy and Infectious Diseases (NIAID). Treatment with Veklury has resulted in faster time to recovery compared to a placebo when treated with a 5-day or 10-day treatment regimen. The drug’s safety and efficacy are yet to be established.
Clinical trial details of Veklury:
The trial involved 1,063 hospitalized patients with COVID-19; 943 patients had severe disease among the patients enrolled. Patients who were on remdesivir recovered in 11 days compared to fifteen days in patients who were on placebo. In severe patients, time to recovery was 12 days for patients who were on remdesivir compared to 18 days for patients who were on placebo. No difference was observed in patients who had mild to moderate disease.
Prior approvals
The drug has already been approved in Japan and the European Union.
Veklury (remdesivir) is an investigational nucleotide analog. The drug is under multiple clinical trials for evaluating the efficacy against COVID-19.
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