Remdesivir, an antiviral drug designed to treat both hepatitis and a common respiratory virus, seemed fated to join thousands of other failed medications after proving useless against those diseases.
But Friday, the Food and Drug Administration issued an emergency approval for remdesivir as a treatment for patients severely ill with COVID-19, the disease caused by the coronavirus, after a federal trial demonstrated modest improvements in severely ill patients.
The trial, sponsored by the National Institute of Allergy and Infectious Diseases, included more than 1,000 hospitalized patients and found that those receiving remdesivir recovered faster than those who got a placebo: in 11 days, versus 15 days. But the drug did not significantly reduce fatality rates.
Dr Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said the results were "a very important proof of concept" but not a "knockout."
Gilead Sciences had dozens of drugs that worked in lab tests to shut down coronaviruses. One of the best was remdesivir, a drug that slipped past the viruses' system to protect RNA, their genetic material. Remdesivir made growing chains of viral RNA terminate prematurely, killing the virus.
Remdesivir killed every known coronavirus in tests. But the drug failed a number of real-life tests against hepatitis and Ebola. The drug languished, unapproved for any use - until a new coronavirus emerged.
As SARS-CoV-2, the virus that causes COVID-19, began to grow into a pandemic, scientists realized that remdesivir might be the best solution at hand. It had already undergone animal testing and safety testing in humans. So doctors began giving it to patients in studies without controls and even outside of studies. Gilead sponsored some of these studies and gave the drug to doctors who treated hundreds of patients under compassionate use, a legal exemption permitting use of an unapproved drug to treat patients.
Not everyone is convinced that remdesivir will live up to its promise. A study in China, published this week in Lancet, found the drug offered no benefit to severely ill patients. And many experts want to see the data from the National Institute of Allergy and Infectious Diseases trial; so far, there have been only announcements about the results from administration officials.
Despite these questions, Gilead has been ramping up production. The drug will be provided to patients at no cost, said Daniel O'Day, the company's chief executive.
