It is the first drug to help fight Covid-19, which has killed more than 230,000 people worldwide.
Donald Trump announced the news on Friday in the White House alongside Stephen Hahn, the Commissioner of the Food and Drug Administration (FDA), who said the drug would be available to hospital patients with Covid-19.
The president said the approval represented “a very promising situation” in the country’s fight against the coronavirus, and Dr. Deborah Birx added: “I think it really illustrates what can happen in such a short time.”
The emergency approval comes just days after Dr. Anthony Fauci, the government’s leading infectious disease expert, expressed cautious optimism about the results of a trial of remdesivir.
“The data shows that remdesivir has a clear, meaningful and positive effect in reducing the recovery time,” said Fauci earlier this week. “What he has proven is that a drug can block this virus. “
The FDA acted after preliminary results from a government-sponsored study showed that Gildes Sciences’ remdesivir shortened recovery time by 31%, or about four days on average, for Covid-19 hospital patients.
The study of 1,063 patients is the largest and most stringent test of the drug and included a comparison group who received usual care so that the effects of remdesivir could be rigorously assessed.
Those who received the drug were able to leave the hospital in an average of 11 days compared to 15 days for the control group. The drug may also reduce deaths, although it’s not certain what partial results have been revealed so far.
Fauci said the drug would become a new standard of care for critically ill Covid-19 patients like those in this study. The drug has not been tested in people with milder disease and is currently administered intravenously in a hospital.
The FDA has authorized the drug under its emergency powers to quickly expedite investigational drugs, tests and other medical products to patients during public health crises.
The FDA normally requires “substantial evidence” of the safety and effectiveness of a drug, usually through one or more rigorously controlled patient studies. But during public health emergencies, the agency may depart from these standards, simply demanding that the potential benefits of an investigational drug outweigh its risks.
Gilead said he would donate his currently available stock of the drug and increase production to do more.
No drug is approved for the treatment of coronavirus and remdesivir will still have to be officially approved.
The FDA can convert the drug’s status to full approval if Gilead or other researchers provide additional data on the safety and effectiveness of remdesivir.
“This is a very, very early step, so you don’t expect to have any full approval at this point,” said Cathy Burgess, a lawyer specializing in FDA matters.
“But they obviously want to communicate this information to patients as quickly as possible.”
The FDA previously authorized the emergency use of a malaria drug, hydroxychloroquine, after Trump repeatedly promoted it as a possible treatment for Covid-19. However, no large, high-quality study has shown that the drug works for this and it has significant safety concerns.
The FDA warned doctors late last month against prescribing the drug outside of hospital or research because of the risk of life-threatening cardiac side effects. Two small studies released Friday add to concerns about the malaria drug.
Hahn said approving the drug for emergency use was “an important clinical advance” in the fight against the coronavirus.
Daniel O’Day, CEO of Gilead, said on Friday that his company has already accelerated production of the drug and hopes to offer millions of courses of treatment by the end of the year.
“I think it’s important to note that this is a drug for the most severe patients,” O’Day said on Today. “What we are seeing here is really, of course, not a cure, but a very, very important and important treatment for patients. “