U.S. regulators on Friday allowed emergency use of an experimental drug that appears to help some coronavirus patients recover faster.
It is the first drug shown to help fight COVID-19, which has killed more than 230,000 people worldwide.
President Donald Trump announced the Gilead authorization during a meeting in the Oval Office with Food and Drug Administration Commissioner Stephen Hahn and Gilead Chief Executive Officer Daniel O’Day. The FDA then immediately released a statement detailing the decision.
The action comes two days after Anthony Fauci, the nation's top infectious-disease expert, announced that trial data showed the drug had a "clear-cut, significant, positive effect in diminishing the time to recovery."
“That is really quite important,” said Fauci, director of the National Institute of Allergy and Infectious Diseases, which is overseeing a study of more than 1,000 patients in the United States and around the world.
The FDA acted after preliminary results from a government-sponsored study showed that Gilead Sciences’s remdesivir shortened the time to recovery by 31%, or about four days on average, for hospitalized COVID-19 patients.
The study of 1,063 patients is the largest and most strict test of the drug and included a comparison group that received just usual care so remdesivir’s effects could be rigorously evaluated.
Those given the drug were able to leave the hospital in 11 days on average versus 15 days for the comparison group. The drug also might be reducing deaths, although that’s not certain from the partial results revealed so far.
The trial began in late February. Reaching the stage where it can be routinely provided to patients in a little over two months "has to be one of the fastest findings for this kind of drug development ever,'' Dr. Paul Goepfert, an infectious disease doctor at the University of Alabama Birmingham and a trial site investigator for the NIAID remdesivir study.
Fauci said the drug would become a new standard of care for severely ill COVID-19 patients like those in this study. The drug has not been tested on people with milder illness, and currently is given through an IV in a hospital.
The FDA authorized the drug under its emergency powers to quickly speed experimental drugs, tests, and other medical products to patients during public health crises.
In normal times the FDA requires “substantial evidence” of a drug’s safety and effectiveness, usually through one or more large, rigorously controlled patient studies. But during public health emergencies the agency can waive those standards, simply requiring that an experimental drug’s potential benefits outweigh its risks.
Gilead has said it would donate its currently available stock of the drug and is ramping up production to make more. Gilead has said it plans to have enough doses for 140,000 people by the end of the month, a supply that could be extended if a finding in a separate Gilead trial holds up that said a five-day course of treatment may be as effective as a 10-day course.
The company has said it believes it can produce 1 million courses of treatment by the end of the year. Gilead said it would coordinate with the government to prioritize cities and hospitals most heavily impacted by coronavirus infections for distribution. Hospitals with intensive care units, which treat the most severely ill patients, will get the drug first, the company said.
No drugs are approved now for treating the coronavirus, and remdesivir will still need formal approval.
The FDA can convert the drug’s status to full approval if Gilead or other researchers provide additional data of remdesivir’s safety and effectiveness.
“This is a very, very early stage so you wouldn’t expect to have any sort of full approval at this point,” said Cathy Burgess, an attorney specializing in FDA issues. “But obviously they want to get this out to patients as quickly as possible.”
The FDA previously gave emergency use authorization to a malaria drug, hydroxychloroquine, after Trump repeatedly promoted it as a possible treatment for COVID-19. No large high-quality studies have shown the drug to work for that, however, and it has significant safety concerns.
The FDA warned doctors late last month against prescribing the drug outside of hospital or research settings, due to risks of sometimes fatal heart side effects.
Two small studies published Friday add to concerns about the malaria drug.
Possible side effects of remdesivir include increased levels of liver enzymes, which may be a sign of inflammation or damage to cells in the liver; and infusion-related reactions, which may include low blood pressure, nausea, vomiting, sweating, and shivering.