The Food and Drug Administration (FDA) has revised the Emergency Use Authorization (EUA) for remdesivir (Veklury; Gilead Sciences) removing the US government’s role in directing the allocation of the investigational coronavirus disease 2019 (COVID-19) treatment.
Remdesivir is a nucleotide analogue with broad-spectrum antiviral activity. It is currently available in the US under an EUA for hospitalized adult and pediatric patients with suspected or laboratory-confirmed COVID-19, regardless of disease severity.
Since the COVID-19 pandemic began, the US Department of Health and Human Services (HHS) was responsible for the allocation and distribution of remdesivir to COVID-19 patients. By increasing manufacturing capacity, Gilead has been able to expand the supply of remdesivir, which now exceeds market demand based on recent allocation numbers from HHS’ Office of the Assistant Secretary for Preparedness and Response.
Under the revised EUA, Gilead Sciences will resume control of the distribution of remdesivir in the US. To ensure stable management of drug supply, AmerisourceBergen will remain the sole US distributor of the product through the end of this year and will sell directly to hospitals. The Company is now able to meet real-time demand for remdesivir and potential future surges of COVID-19.
“Over the past 5 months, HHS rapidly, fairly, and equitably worked to distribute approximately 150,000 treatment courses of donated Veklury and make more than 500,000 treatment courses of the commercial drug available to help treat patients in US hospitals,” said HHS Secretary Alex Azar. “Now, federal government oversight of the allocation of Veklury is not required because the drug is no longer a scarce resource—a tribute to progress we have made against COVID-19 and to the strength of our partnerships with the private sector.”
A New Drug Application (NDA) for remdesivir for the treatment of COVID-19 was submitted to the FDA in August 2020. The application includes data from two phase 3 clinical studies that showed a faster time to recovery in patients treated with remdesivir compared with placebo.
For more information visit gilead.com.
- Gilead Sciences update on supply and distribution of Veklury® (remdesivir) in the United States. https://www.businesswire.com/news/home/20201001006002/en/Gilead-Sciences-Update-on-Supply-and-Distribution-of-Veklury%C2%AE-remdesivir-in-the-United-States. Accessed October 2, 2020.
- Veklury (remdesivir) now available directly from distributor following Trump administration’s successful allocations to states and U.S. territories. https://www.hhs.gov/about/news/2020/10/01/veklury-remdesivir-available-directly-distributor-following-trump-administrations-successful-allocations.html. Accessed October 5, 2020.