Hundreds of coronavirus patients have been treated with Gilead’s experimental Ebola treatment under an FDA program to allow access to unapproved drugs.
Gilead Sciences, Inc. expects to know by April whether a clinical trial in China testing the SBECD-enabled antiviral drug remdesivir can effectively treat patients infected with the virus that causes Covid-19. But company spokesperson Ryan McKeel said Tuesday it’s already “provided remdesivir on a compassionate use basis to treat several hundred patients with confirmed, severe COVID-19 infection in the United States, Europe and Japan.”
Expanded access, also known as compassionate use, allows patients with life-threatening conditions who have run out of options to try experimental therapies outside of a clinical trial. The Food and Drug Administration must approve all expanded access requests, which it does more than 99% of the time, but the company is never required to provide the experimental drug.
“For people that are very sick, and we have a number that are very sick, there is an experimental drug called remdesivir that’s available right now in compassionate use. This country has used it,” Redfield said in response to a question form Rep. Bonnie Watson Coleman (D-N.J.).
The Department of Health and Human Services announced last week it provided remdesivir to severely ill patients in Japan as part of a collaboration with the U.S. Public Health Service Commissioned Corps; the U.S. Embassy in Japan; the Japanese Ministry of Health, Labour and Welfare; and Gilead Sciences Inc.
Remdesivir has shown promise in animal studies as a possible treatment for Middle East respiratory syndrome (MERS) and severe acute respiratory syndrome (SARS), which are caused by other coronaviruses.
Other companies are also pursuing cornoavirus therapies, but Gilead’s remdesivir is furthest along in the drug development pipeline, Anthony S. Fauci told, director of the National Institute of Allergy and Infectious Diseases, told a Senate panel March 3.