What Is Remdesivir? The Experimental Drug Being Used To Treat Coronavirus Patients
Though the drug is not approved by the FDA, “positive data” has been emerging about remdesivir and its treatment of the virus.
Researchers say the experimental drug remdesivir might help patients recover more quickly from the coronavirus.
A federal trial by the National Institute of Allergy and Infectious Diseases published Wednesday found patients using the drug were able to recover from COVID-19 four days faster than patients on a placebo. The study also found an 8% mortality rate in patients on remdesivir compared to 11% for the placebo group. The findings have not yet been peer-reviewed.
American biotech company Gilead Sciences, which makes remdesivir, began research on the experimental drug as early as 2009. The company studied the drug as a possible treatment for Ebola during the 2014 outbreak and for other coronaviruses like SARS and MERS.
On Wednesday, Gilead said in a statement that it is "aware of positive data emerging" from the federal trial, but said that the drug is not yet licensed or approved anywhere and has not yet demonstrated to be a safe, effective treatment for COVID-19.
NIAID director and White House health adviser Dr. Anthony Fauci also noted the drug’s potential to modestly speed up recovery times in patients infected with the virus at a Wednesday briefing.
While prefacing that remdesivir "doesn’t seem like a knockout 100 percent," Dr. Fauci said "it is a very important proof of concept, because what it has proven is that a drug can block this virus."
The Food and Drug Administration (FDA) has not approved any drug for treating the coronavirus. But the New York Times reported on Wednesday that the FDA will likely soon announce an emergency authorization use of remdesivir to treat COVID-19 patients, though the drug has not yet been approved for any disease.
In a statement to CNN, the FDA also said on Thursday that it is in talks with Gilead about making the drug available to patients.
"As part of the FDA's commitment to expediting the development and availability of potential COVID-19 treatments, the agency has been engaged in ... discussions with Gilead Sciences regarding making remdesivir available to patients as quickly as possible, as appropriate," FDA spokesman Michael Felberbaum said in the provided statement.
A competing study on remdesivir found that the drug was "not associated with statistically significant clinical benefits." Despite this, Dr. Fauci said that the use of remdesivir could happen "really quickly," during a Thursday appearance on NBC's "Today" show.
"I would project that we’re going to be seeing that reasonably soon," he said.
Researchers have been working extensively to find a treatment for the virus, which has killed more than 60,000 Americans and infected more than 1 million, according to the Johns Hopkins University tracker.
The FDA’s Emergency Use Authorization program allows the agency to authorize the use of an unapproved medical product or an unapproved use of an approved medical product during a serious public health emergency like the coronavirus.
The agency previously issued emergency authorization of the malaria drugs hydroxychloroquine and chloroquine to be used on hospitalized coronavirus patients. Last week, the agency warned against using the drug outside of clinical trials or hospitals after it was found to cause heart problems in patients.