The US Food and Drug Administration issued an emergency-use authorization on Friday for remdesivir in hospitalized patients with severe Covid-19.
The FDA said it issued the authorization based in part on the results from a trial sponsored by the National Institutes of Health, the results of which were announced by Dr. Anthony Fauci on Wednesday. The infused drug reduced the time of illness in some severely affected patients.
What this means: An emergency-use authorization is a lower regulatory bar than full FDA approval, but it’s a sign that the FDA believes the benefits of a drug outweigh its risks in certain patients.
The FDA limited its authorization of the drug to adults and children with suspected or laboratory-confirmed Covid-19 and severe disease. The drug is administered in a hospital setting via IV by a healthcare provider
The CEO of Gilead Sciences, the maker of remdesivir, said in an open letter on Wednesday that the company’s existing supply of the drug could cover at least 140,000 treatment courses for patients with Covid-19.
