Emergency Use Authorization Granted to Investigational Antiviral for COVID-19
Remdesivir is not approved by the FDA. However, EUA allows for distribution and emergency use for treatment of COVID-19.
Officials with the FDA have granted emergency use authorization (EUA) to Gilead Sciences’ investigational drug remdesivir for treatment of the coronavirus disease 2019 (COVID-19). The EUA will allow for broader use of remdesivir for hospitalized patients with severe COVID-19, according to Gilead.1,2
Remdesivir was designated for ‘compassionate use’ in March 2020, allowing patients with serious or life-threatening case of the virus to have access to the drug.3 The antiviral drug has also been granted Orphan Drug status by the FDA.4
Remdesivir is not approved by the FDA, and the temporary EUA does not take the place of the formal new drug application submission, review and approval process. EUA allows for distribution and emergency use only for treatment of COVID-19.1
“From day 1, the FDA has been committed to expediting the development and availability of potential COVID-19 treatments. Today’s action is an important step in our efforts to collaborate with innovators and researchers to provide sick patients timely access to new therapies where appropriate, while at the same time supporting research to further evaluate whether they are safe and effective,” said FDA Commissioner Stephen M. Hahn, MD, in a prepared statement. “There’s tremendous interest among all parties to identify and arm ourselves with medicines to combat COVID-19, and through our Coronavirus Treatment Acceleration Program, the FDA is working around-the-clock and using every tool at our disposal to speed these efforts.”2
Allocation of the currently limited available supply of remdesivir will be made based on guiding principles that aim to maximize access for appropriate patients in urgent need of treatment, with direction from and in collaboration with the government, according to Gilead.1
Under the EUA, 5-day and 10-day treatment durations are suggested, based on the severity of disease. The optimal duration of treatment with remdesivir is still being studied in ongoing clinical trials.1
New data from a phase 3 SIMPLE trial, announced by Gilead earlier this week, showed positive results with an evaluation of 5-day and 10-day dosing durations of remdesivir in hospitalized patients with severe manifestations of COVID-10. The study demonstrated that a 10-day treatment course of remdesivir achieved similar improvement in the clinical status of patients with COVID-19 as a 5-day treatment course (Odds Ratio: 0.75 [95% CI 0.51 — 1.12] on Day 14).5
In addition, the federal Health and Human Services (HHS) Secretary Alex Azar, noted that the FDA’s EUA designation comes 2 days after a clinical trial by National Institutes of Health (NIH) showed also promising results for remdesivir.2
“NIH, FDA, and scientists across America and around the world have worked tirelessly with patients to get us this new potential treatment for COVID-19,” said Azar, in a prepared statement.2
According to Gilead, given the severity of illness in patients deemed appropriate for remdesivir treatment and the limited availability of drug supply, hospitals with intensive care units and others most in need will receive priority in the distribution of remdesivir. Gilead is working with the US government on the logistics of remdesivir distribution and will provide more information when the company begins shipping the drug under the EUA.1
“This EUA opens the way for us to provide emergency use of remdesivir to more patients with severe symptoms of COVID-19,” said Daniel O’Day, Chairman and Chief Executive Officer of Gilead Sciences, in a prepared statement. “We will continue to work with partners across the globe to increase our supply of remdesivir while advancing our ongoing clinical trials to supplement our understanding of the drug’s profile. We are working to meet the needs of patients, their families and healthcare workers around the world with the greatest sense of urgency and responsibility.”1
Serious and unexpected adverse events that have not been previously reported with remdesivir use may occur in patients taking remdesivir. In clinical studies with remdesivir, infusion-related reactions and liver transaminase elevations have been observed, Gilead warned.1
- Gilead’s Investigational Antiviral Remdesivir Receives U.S. Food and Drug Administration Emergency Use Authorization for the Treatment of COVID-19 [news release]. Foster City, CA; May 1, 2020: Gilead Sciences. [email] Accessed May 1, 2020.
- Coronavirus (COVID-19) Update: FDA Issues Emergency Use Authorization for Potential COVID-19 Treatment [news release]. Silver Spring, MD; May 1, 2020. FDA website. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-issues-emergency-use-authorization-potential-covid-19-treatment Accessed May 1, 2020.
- Coppock K. FDA Announces Two Drugs Given ‘Compassionate Use’ Status in Treating COVID-19. Pharmacy Times website. https://www.pharmacytimes.com/news/fda-announces-two-drugs-approved-for-compassionate-use-in-treating-covid-19 Published March 19, 2020. Accessed April 29, 2020.
- Hippensteele A. Potential COVID-19 Treatment Granted Orphan Drug Status. Pharmacy Times website. https://www.pharmacytimes.com/news/potential-covid-19-treatment-granted-orphan-drug-status Published March 25, 2020. Accessed April 29, 2020.
- Coppock K. Remdesivir Demonstrates Positive Results in Phase 3 Trial for COVID-19. Pharmacy Times website. https://www.pharmacytimes.com/news/remdesivir-demonstrates-positive-results-in-phase-3-trial-for-covid-19 Published April 29, 2020. Accessed May 1, 2020.