Gilead's antiviral drug remdesivir has been authorised by U.S. regulators for emergency use on coronavirus patients, President Donald Trump announced Friday.
Remdesivir is an investigational antiviral medicine to treat certain people in the hospital with COVID-19, said the FDA, adding the drug is still being studied.
Meanwhile, the FDA in an email statement to Reuters, reiterated it was in talks with Gilead about making the drug available to patients as quickly as possible.
Vice President Mike Pence said 1.5 million vials would start being distributed to hospitals on Monday.
The FDA's emergency use authorization increases access by allowing any doctor "to prescribe remdesivir for their patients who are hospitalized with COVID-19", Dr. William Schaffner, an infectious disease expert at Vanderbilt University Medical Center, explained.
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.
Gilead did not immediately respond to a request for the price it plans to charge for the drug after its pledged donations are used up.
Gilead said the federal government will coordinate the donation and distribution of remdesivir to hospitals in cities hardest hit by COVID-19. Information about dosing and potential safety issues will be provided to physicians and patients, the FDA said.
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The news comes days after preliminary results from a study of the drug showed it can help patients recover faster.
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.
Remdesivir is given to patients through a vein one time each day for up to 10 days depending on recommendations of healthcare providers, according to the FDA. But during public health emergencies the agency can waive those standards and require only that an experimental drug's potential benefits outweigh its risks. Through Gilead's trials, more than 181 hospital locations around the world, including hospitals in 27 US states, have been administering the drug.
No drugs are approved now for treating the coronavirus, and remdesivir will still need formal approval. There are also Canadian trials looking at remdesivir's effectiveness, along with that of other potential treatments.
"Given there are no adequate, approved, or available alternative treatments, the known and potential benefits to treat this serious or life-threatening virus now outweigh the known and potential risks of the drug's use", the FDA wrote in a press release.
It is not yet licensed or approved anywhere globally while multiple Phase 3 studies are ongoing to determine the safety and efficacy of the drug for the treatment of COVID-19.
Marchione reported from Milwaukee. The AP is exclusively responsible for all content.