Coronavirus drug combo, baricitinib plus remdesivir, gets FDA emergency approval
November 20, 2020 at 15:14
The U.S. Food and Drug Administration (FDA) on Thursday issued emergency approval to a drug combo to treat moderate to seriously ill coronavirus patients.
The combo, rheumatoid arthritis drug baricitinib plus Gilead's remdesivir, was authorized to treat hospitalized patients 2 years or older requiring oxygen.
The FDA said the drugs cut patients’ time to recovery in a National Institute of Allergy and Infectious Diseases-sponsored trial dubbed the Adaptive COVID-19 Treatment Trial (ACTT-2).
Among 1,033 coronavirus patients in the trial with at least a moderate course of disease, patients on the drug combo saw seven days to recovery, while the other group (placebo plus remdesivir) took eight days.
“The odds of a patient’s condition progressing to death or being ventilated at day 29 was lower in the baricitinib plus remdesivir group versus the placebo plus remdesivir group,” the FDA wrote in a statement.
PFIZER TO FILE CORONAVIRUS VACCINE FOR EMERGENCY USE AUTHORIZATION: HERE'S WHAT IT MEANS“The safety and effectiveness of this investigational therapy for use in the treatment of COVID-19 continues to be evaluated,” reads the statement.
Baricitinib, sold under the brand name Olumiant, works by interfering with a process leading to inflammation.
That approval followed results published in the New England Journal of Medicine from Gilead's Phase 3 ACTT-1 trial, which demonstrated faster recovery times than previously reported for the treatment of adults hospitalized with mild-moderate or severe coronavirus cases.
Remdesivir was also found to reduce disease progression among severely ill patients who require oxygen.
However, on Friday, a WHO panel advised against using remdesivir in hospitalized coronavirus patients, citing "little or no effect" in patients following a multicountry Solidarity Trial.
Fox News' Alexandria Hein and Lucas Manfredi contributed to this report.
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