Coronavirus drug combo, baricitinib plus remdesivir, gets FDA emergency approval

multiexposure background of china coronavirus COVID-19 infected blood sample in sample tube with DNA strain

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.

“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.

“The FDA’s emergency authorization of this combination therapy represents an incremental step forward in the treatment of COVID-19 in hospitalized patients, and FDA’s first authorization of a drug that acts on the inflammation pathway,” Dr. Patrizia Cavazzoni, acting director of the FDA’s Center for Drug Evaluation and Research, said in the statement. “Despite advances in the management of COVID-19 infection since the onset of the pandemic, we need more therapies to accelerate recovery and additional clinical research will be essential to identifying therapies that slow disease progression and lower mortality in the sicker patients.”

Meanwhile, Gilead’s remdesivir had already seen FDA-approval as the first COVID-19 treatment for patients over 12. 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. Gilead has disputed these claims.