U.S. regulators on Friday allowed emergency use of the first drug that appears to help some COVID-19 patients recover faster, a milestone in the global search for effective therapies against the coronavirus.
The Food and Drug Administration said in a statement that Gilead Science’s intravenous drug would be specifically indicated for hospitalized patients with “severe disease,” such as those experiencing breathing problems requiring supplemental oxygen or ventilators.
President Donald Trump announced the news at the White House alongside Gilead CEO Daniel O’Day and Food and Drug Administration Commissioner Stephen Hahn.
“This was lightning speed in terms of getting something approved” said Hahn, calling the drug “an important clinical advance.”
The FDA acted after preliminary results from a government-sponsored study showed that the drug, 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 vs. 15 days for the comparison group. The drug may also help avert deaths, but the effect is not yet large enough for scientists to know for sure.
Dr. Sameer Khanijo, a critical care specialist, said he wants to see additional studies to clarify the drug’s benefit.
“I don’t think this is a cure yet, but I think it’s starting to point us in the right direction,” said Khanijo of North Shore University Hospital in New York. “As a society it’s nice to have something that will help stem the tide of this disease.”
The FDA said preliminary results for federal researchers warranted Friday’s decision, though regulators acknowledged “there is limited information known about the safety and effectiveness of using remdesivir.”
The drug’s side effects include potential inflammation of the liver and problems related to its infusion, which could lead to nausea, vomiting, sweating and low blood pressure. Information about dosing and potential safety issues will be provided to physicians and patients, the FDA said.
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