The FDA has issued an emergency-use authorisation (EUA) to Gilead Sciences' remdesivir for the treatment of adults and children with severe COVID-19 after recent data from a government-led study suggested the experimental antiviral medicine shortened the time to recovery in hospitalised patients with advanced disease by 31% compared to placebo. US President Donald Trump made the announcement about the FDA action on Friday at the White House.
Gilead CEO Daniel O'Day said "this EUA opens the way for us to provide emergency use of remdesivir to more patients with severe symptoms of COVID-19." The agency noted that "severe disease" in this case is defined as patients with low blood oxygen levels, or needing oxygen therapy or more intensive breathing support, such as a mechanical ventilator.
Earlier this week, preliminary results from the Phase III ACTT trial being conducted by the US National Institute of Allergy and Infectious Diseases showed that median time to recovery was 11 days for patients treated with up to a 10-day course of remdesivir, compared with 15 days for placebo. Based on the available evidence, the FDA said "it is reasonable to believe that remdesivir may be effective in treating COVID-19, and that, given there are no adequate, approved, or available alternative treatments, the known and potential benefits…outweigh the known and potential risks."
According to Gilead, the US government will coordinate the donation and distribution of remdesivir to hospitals in cities most heavily impacted by the coronavirus pandemic. "Hospitals with intensive care units and other hospitals that the government deems most in need will receive priority in the distribution of remdesivir," due in part to limited availability of drug supply, the company said. Gilead added that it is working with the US government on remdesivir distribution and will provide more information when it begins shipping the drug under the EUA. During a meeting in the Oval Office with President Trump, O'Day said the company was donating 1.5 million vials of the drug to help patients.
O'Day further noted that the company is also working with partners around the world "to increase our supply of remdesivir." During Gilead's recent first-quarter results presentation, the drugmaker indicated that it would focus on making remdesivir "both accessible and affordable to governments and patients around the world." In April, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended compassionate use of remdesivir to treat COVID-19.
Meanwhile, the FDA also issued an emergency-use authorisation at the end of March to allow hydroxychloroquine and chloroquine products donated to the Strategic National Stockpile to be used to treat hospitalised adults and adolescents with COVID-19, when a clinical trial is not available or feasible.
For related analysis, listen to our latest podcast from FirstWord executive editors Simon King and Michael Flanagan, which includes a discussion on the effectiveness of remdesivir in light of the ACTT trial data.
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