FDA Issues emergency-use authorization allowing use of remdesivir
The federal Food and Drug Administration has issued emergency-use authorization for a drug tested at University of Virginia Health to be used against COVID-19. The antiviral drug, remdesivir, becomes the first treatment authorized to battle the life-threatening illness.
The authorization clears remdesivir for use for hospitalized adults and children with severe cases of COVID-19, such as those requiring supplemental oxygen or ventilation.
UVA Health leaders are already working to make the treatment available to patients.
“This is an important step forward in the battle against COVID-19,” said K. Craig Kent, M.D., UVA’s executive vice president for health affairs. “I congratulate everyone at UVA who played a part in bringing this much-needed new treatment to patients, and I thank them – and all our care providers – for all their hard work and dedication.”
Faculty in infectious diseases, critical care and pharmacy are reviewing the latest guidance from the FDA to ensure that patients at UVA can benefit from remdesivir as rapidly as possible.
“We are immensely grateful to the patients who participated in this important clinical trial and their families,” said Patrick Jackson, M.D., the trial’s principal investigator at UVA. “Their generosity will have an immediate impact for patients with COVID-19 around the world.”
Gilead Sciences, the maker of remdesivir, has said that it hopes to make millions of doses available by the end of the year.
“We really needed to have a solid win in the fight against COVID-19,” said Taison Bell, M.D., a UVA critical care and infectious disease specialist. “This is an important moment in history, and I’m proud to say that UVA was a part of it.”
At a press conference Friday, President Donald Trump was joined by Gilead CEO Dan O’Day.
“I’m pleased to announce that Gilead now has an EUA from the FDA for remdesivir,” Trump said. “And you know what that is because that’s been the hot thing also in the papers and in the media for the last little while. An important treatment for hospitalized coronavirus patients. And it’s something – I spoke with (FDA Commissioner Dr. Stephen) Hahn and (National Institute of Allergy and Infectious Diseases Director Dr. Anthony) Fauci; I spoke with (U.S. Global AIDS Coordinator & U.S. Special Representative for Global Health Diplomacy Dr. Deborah Birx) about it. And it’s – it’s really a very promising situation.
“We’ve been doing work with the teams at the FDA, NIH and Gilead for spearheading this public-private partnership to make this happen very quickly.
“We have very promising studies coming out on the vaccines. We have promising studies coming out on therapeutics.”
O’Day said, “We feel a tremendous responsibility. We’re humbled by this being an important first step for patients, for hospitalized patients. We want to make sure nothing gets in the way of these patients getting the medicine. So, we made a decision to donate about 1.5 million vials of remdesivir.
“We’ll be working with the government to determine how best to distribute that within the United States. We’ll be working very closely to get that to patients, working with FEMA, working with other parts of the government to make sure that we get that to the patients in need as quickly as possible, because there are patients out there that can benefit from this medicine today that are hospitalized, and we don’t want any time to waste for that.
“And we’re also fully committed to continue to expand the supply of this medicine. We started investing in this back in January, as soon as we became aware of the coronavirus. This is a long time to manufacture. It used to be 12 months; it’s now SIX months. Our scientists have brought that down.
“And so, as we get into the second half of this year, we’re able to have many more supplies available to patients. And we’re fully committed to working, Mr. President, with you and your administration to make sure that patients in need can get this important new medicine.”
He later added, “It’s early days on coronavirus. I think this is the first step today. And I think what we’ll see – and it may be like with other viruses that we’ve seen: that with this base step, with an antiviral like remdesivir, that the way to actually even get better results is to add medicines on top of an antiviral. That has been – that was really how we were able to get HIV to a chronic illness: by a combination of therapies.”
Remdesivir Trial Results
Tested at UVA Health and 67 other sites around the world, remdesivir helped patients with advanced cases of COVID-19 recover 31% faster than patients who received a placebo, according to preliminary trial results released by the National Institutes of Health. The median recovery time for patients who received remdesivir was 11 days, compared with 15 days for those who received placebo.
Remdesivir also appeared to improve survival: 8% of remdesivir recipients died, compared with 11.6% of placebo recipients.
About the Trial
The Adaptive COVID-19 Treatment Trial, or ACTT, was the first trial of a potential medication to treat COVID-19 launched in the U.S. By the time enrollment was completed on April 19, a total of 1,063 patients had enrolled in the randomized, controlled trial, the NIH reported.
Hospitalized adult patients with COVID-19 and significant symptoms – including difficulty breathing, using supplemental oxygen or needing a ventilator – were eligible to participate. Participants were assigned at random to receive either remdesivir or a placebo intravenously for as long as 10 days.
For the study’s purposes, “recovery” was defined as being well enough to leave the hospital or return to normal activities.
UVA Health is an academic health system that includes a 612-bed hospital, the UVA School of Medicine, a level I trauma center, nationally recognized cancer and heart centers, and primary and specialty clinics throughout Central Virginia. UVA is recognized for excellence by U.S. News & World Report, Best Doctors in America and America's Top Doctors.