Gilead’s Remdesivir Receives Expanded FDA EUA for Treatment of All Hospitalized COVID-19 Patients

The US Food and Drug Administration (FDA) has broadened the scope of the existing emergency use authorization (EUA) for Gilead Sciences’ (Foster City, CA, USA) antiviral drug remdesivir to include treatment of all hospitalized adult and pediatric patients with suspected or laboratory-confirmed COVID-19, irrespective of their severity of disease.

Remdesivir is being studied in multiple ongoing international clinical trials and has been approved by multiple regulatory authorities around the world, including in the European Union and Japan. Remdesivir has not been approved by the US FDA for any use but had been granted an Emergency Use Authorization (EUA) in the US for the treatment of hospitalized patients with severe COVID-19, which was defined as patients with low blood oxygen levels or needing oxygen therapy or more intensive breathing support such as a mechanical ventilator.

Based on the FDA’s ongoing review of the EUA, including its review of the totality of scientific information now available, the agency believes that it is reasonable to believe that remdesivir may be effective for the treatment of suspected or laboratory-confirmed COVID-19 in all hospitalized adult and pediatric patients. The FDA’s review has also concluded that the known and potential benefits of remdesivir outweigh the known and potential risks for these uses. As a result, the FDA has revised the EUA to expand the scope of the authorized uses of remdesivir to include the treatment of hospitalized adult and pediatric patients, irrespective of their disease severity. The expansion of the scope of the EUA to include hospitalized patients with mild or moderate COVID-19 is supported by the FDA’s analysis of additional data from two randomized, controlled clinical trials that included patients with mild or moderate disease.

“The FDA continues to make safe and potentially helpful treatments for COVID-19 available as quickly as possible in order to help patients. The data to support today’s action are encouraging. The data show that this treatment has the potential to help even more hospitalized patients who are suffering from the effects of this devastating virus,” said FDA Commissioner Stephen M. Hahn, M.D. “We are working with drug developers to conduct randomized clinical trials to further study the safety and effectiveness of a number of potential therapies for COVID-19.”

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