FDA approves emergency treatment for COVID-19 with new combination of drugs
The US Food and Drug Administration (FDA) on Thursday, November 19, issued an emergency authorization for the combination drug for the treatment of patients with moderate to severe COVID-19 disease. Fox News.
A combination regimen combining the rheumatoid arthritis drug baricitinib and remdesivir (both from Gilead) has been approved for the treatment of hospitalized patients 2 years of age or older who require oxygen. The FDA said the drugs shorten the patient's recovery time. These findings were made in a study sponsored by the National Institute of Allergy and Infectious Diseases, called the Adaptive COVID-19 Treatment Trial (ACTT-2).
Among the 1033 coronavirus patients in the study with at least a mild course of illness, the patients who took this combination of drugs recovered after 7 days, while the other group (placebo plus remdesivir) took eight days.
"The likelihood of patient progression to death or mechanical ventilation on day 29 was lower in the baricitinib-remdesivir group compared to the placebo-remdesivir group," the FDA said in a statement.
“The safety and efficacy of this research therapy for the treatment of COVID-19 continues to be evaluated,” the statement said.
Baricitinib, marketed under the brand name Olumiant, inhibits the process that leads to inflammation.
"The FDA's emergency clearance for this combination therapy represents a gradual step forward in the treatment of COVID-19 in hospitalized patients, as well as the first FDA approval for a drug that works against inflammation," said Dr. Patricia Cavazzoni, acting FDA director. “Despite advances in managing COVID-19 infection since the start of the pandemic, we need more treatments to accelerate recovery, and more clinical research will be needed to identify treatments that slow disease progression and reduce mortality in severely ill patients.”
Meanwhile, Gilead's remdesivir has already received FDA approval as the first treatment for COVID-19 for patients over 12 years old. This approval follows the results of a study published in the New England Journal of Medicine, which showed faster recovery times than before. Treatment has been reported for adults hospitalized with mild, moderate, or severe COVID-19. Remdesivir also reduces the progression of the disease in critically ill patients requiring oxygen.
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However, on Friday, November 20, a WHO expert group advised against the use of remdesivir for hospitalized coronavirus patients, citing "little or no effect" in patients after international trials. Gilead disputed these claims.
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