Gilead’s Remdesivir Receives US FDA Emergency Use Authorization for Treatment of COVID-19

Gilead Sciences’ (Foster City, CA, USA) investigational antiviral drug remdesivir has been granted emergency use authorization (EUA) to treat COVID-19 by the US Food and Drug Administration (FDA).

The EUA is based on available 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, including those who were critically ill, and Gilead’s global Phase 3 study evaluating 5-day and 10-day dosing durations of remdesivir in patients with severe disease. Multiple additional clinical trials are ongoing to generate more data on the safety and efficacy of remdesivir as a treatment for COVID-19. The optimal duration of treatment is still being studied in ongoing clinical trials.

Under the EUA, the 10-day dosing duration is suggested for patients requiring invasive mechanical ventilation and/or extracorporeal membrane oxygenation (ECMO), and the 5-day dosing duration is suggested for patients not requiring invasive mechanical ventilation and/or ECMO. If a patient on the 5-day dosing duration does not demonstrate clinical improvement after five days, treatment may be extended for up to five additional days (10 days total).

The EUA will facilitate broader use of remdesivir to treat hospitalized patients with severe COVID-19 disease, enabling access to the drug at additional hospitals across the US. The government will coordinate the donation and distribution of remdesivir to hospitals in cities most heavily impacted by COVID-19. Given the severity of illness of patients appropriate for remdesivir treatment and the limited availability of drug supply, hospitals with intensive care units and other hospitals that the government deems 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.

Gilead has aggressively implemented a multipronged approach to scale up production and rapidly build supply of remdesivir. The company has set a goal of producing at least 500,000 treatment courses by October, 1 million treatment courses by December 2020 and millions more in 2021, if required. These goals were based on a 10-day treatment course. Gilead now anticipates being able to cover significantly more patients based on the SIMPLE study results, which demonstrated similar efficacy with 5-day and 10-day dosing durations in patients with severe disease.

“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. “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.”

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