FDA Authorizes Emergency Use of Remdesivir to Treat COVID-19

FDA recently granted emergency use authorization (EUA) to Gilead for the investigational antiviral, remdesivir, to treat COVID-19 patients. 

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The EUA allows for remdesivir to be distributed in the US and administered intravenously by healthcare providers, as appropriate, to treat COVID-19 in adults and children hospitalized with severe disease.

Additionally, the EUA requires fact sheets to give healthcare providers and patients vital information about using remdesivir in treating COVID-19. This includes dosing instructions, potential side effects and drug interactions.

“FDA’s emergency authorization of remdesivir, two days after the National Institutes of Health’s clinical trial showed promising results, is a significant step forward in battling COVID-19 and another example of the Trump Administration moving as quickly as possible to use science to save lives,” HHS Secretary Alex Azar, said in the announcement. 

“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. The seamless cooperation between government and private industry under the President’s all-of-America approach to COVID-19 is getting treatment options to patients in record time.”

The EUA was based on data from two global clinical trials, the National Institute for Allergy and Infectious Diseases’ placebo-controlled Phase 3 study in patients with moderate to severe symptoms of COVID-19 and Gilead’s global Phase 3 study. 

Gilead’s study found that using remdesivir as a COVID-19 treatment for severe coronavirus patients produced positive results. Severe patients receiving a ten-day treatment of remdesivir achieved similar clinical improvement compared with those taking a five-day treatment course. 

Clinical improvement for 50 percent of patients was ten days in the five-day treatment group and 11 days in the ten-day treatment group, researchers stated. Over half of patients in both treatment groups were discharged from the hospital by day 14. At day 14, 64.5 percent of patients in the five-day treatment group and 53.8 percent of patients in the 10-day treatment group achieved clinical recovery.

Outside of Italy, the overall mortality rate at day 14 was seven percent across both treatment groups, with 64 percent of patients experiencing clinical improvement at day 14 and 61 percent of patients discharged from the hospital.

Several other clinical trials are ongoing to generate more data on the safety and efficacy of remdesivir as a treatment for COVID-19. But the EUA is opening the way for Gilead to start offering the drug as a COVID-19 treatment, Daniel O’Day, chairman and chief executive officer of Gilead Sciences, said in a press release.

“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,” O’Day stated. “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.”

Gilead noted that under the EUA, the ten-day dosage duration is suggested for patients requiring invasive mechanical ventilation and/or extracorporeal membrane oxygenation (ECMO). The five-day dosing duration is suggested for patients not requiring invasive mechanical ventilation. 

The biopharmaceutical company previously donated its existing supply of finished and unfinished product to help address COVID-19 medical needs. Assuming a ten-day treatment course, Gilead said its donation of 1.5 million doses of remdesivir equals more than 140,000 treatment courses, which will be provided at no cost to patients following potential emergency authorizations and regulatory approvals, including the EUA.

“Gilead will continue to support clinical trials, and expanded access and compassionate use programs for remdesivir. In addition, Gilead will evaluate global allocation of supply on an ongoing basis using multiple, independent data sources to track the incidence and severity of the outbreak,” the company concluded.