On Friday, the Food and Drug Administration gave emergency approval for the emergency treatment of the COVID-19 coronavirus with the use of remdesivir. The drug has been trialed as an experimental treatment in patients with the virus. The federal trial of the antiviral medication showed that remdesivir, which is manufactured by Gilead Sciences, shortened the course of COVID-19 and sped up the recovery rate.
“I’m pleased to announce that Gilead now has an emergency waiver from the FDA for remdesivir…for hospitalized coronavirus patients.,” Trump announced with Gilead CEO, Dan O’Day.
Emergency approval of a drug is not the same as formal drug approval by the FDA. The swift action to approve a drug is possible when the federal government has made a national declaration of a public health emergency and there is no current treatment for an outbreak.
Trump had previously consulted with the White House’s coronavirus task force physicians, Dr. Deborah Birx and Dr. Anthony Fauci, as well as FDA commissioner Stephen Haun. All had agreed that remdesivir showed promise as a treatment for the virus.
Dr. Fauci had noted on Wednesday, “It is a very important proof of concept, because what it has proved is that a drug can block this virus. This is very optimistic,” Fauci said, hailing early trial results.
Trump added, “We’ve been doing work with teams at the FDA and NIH, and Gilead has been spearheading this public-private partnership to make this happen very quickly.”
Dr. Birx also said, “I think this really illustrates what can happen in such a short time. From the first case that was diagnosed in the United States to now, our first step forward with a therapeutic in less than 90 days.”
According to Dr. William Schaffner, the move by the FDA should increase access to remdesivir and allow a doctor to prescribe the drug for hospitalized coronavirus patients. Schaffner, an infectious disease doctor with the Vanderbilt University Medical Center, cautioned that not all patients should receive the drug. “Ongoing clinical trials will define which patients will best benefit from remdesivir treatment.”
The FDA also cautions that the drug is still in its experimental stages.
“There is no U.S. Food and Drug Administration approved product available to treat COVID-19.” Some people with certain conditions, such as kidney or liver problems, allergies, and pregnant women should consult their doctor before taking remdesivir because they could be more prone to serious adverse reactions. Certain medications and herbal medications can also alter how a patient will respond to remdesivir.
The trial for remdesivir enrolled 1,063 coronavirus patients. Some were given the drug, while others received a placebo. Recovery time averaged 11 days for those who received the medication. Patients who received a placebo averaged 15 days recovery time.