[ad_1]
The United States Food and Drug Administration (FDA) on Thursday issued emergency approval for a drug combo to treat moderate to critically ill coronavirus patients.
Gilead’s rheumatoid arthritis medicine baricitinib and remdesivir were approved for use in hospital patients 2 years of age or older requiring oxygen. The FDA said the drugs shortened patient recovery times in a trial sponsored by the National Institute of Allergy and Infectious Diseases dubbed the COVID-19 Adaptive Treatment Trial (ACTT-2).
Of the 1,033 coronavirus patients in the trial with at least a moderate course of the disease, the patients on the drug combo saw seven days to recover, while the other group (placebo plus remdesivir) took eight days.
“The likelihood of a patient’s condition progressing to death or being ventilated on day 29 was lower in the baricitinib plus remdesivir group compared to the placebo plus remdesivir group,” the FDA wrote in a statement.
The United States Food and Drug Administration (FDA) on Thursday issued emergency approval for a drug combo to treat hospital patients with moderate to critically ill coronaviruses. (iStock)
PFIZER FILES CORONAVIRUS VACCINE FOR EMERGENCY USE AUTHORIZATION: THIS IS WHAT IT MEANS
“The safety and efficacy of this experimental therapy for use in the treatment of COVID-19 continues to be evaluated,” the statement read.
Baricitinib, sold under the brand name Olumiant, works by interfering with a process leading to inflammation.
“FDA Emergency Clearance of Combination Therapy is a Step Forward in Treatment of COVID-19 in Hospital Patients, and FDA’s First Clearance of Inflammation Pathway Drug Dr. Patrizia Cavazzoni, acting director of the FDA Center for Drug Evaluation and Research, said in the statement. “Despite the progress made in managing COVID-19 infection since the onset of the pandemic, we need more therapies to speed recovery and further clinical research will be essential to identify therapies that slow the progression of disease and reduce mortality in the sickest patients. “
Meanwhile, Gilead’s remdesivir had already been approved by the FDA as the first COVID-19 treatment for patients over 12 years of age. This approval followed results published in the New England Journal of Medicine of Gilead’s phase 3 ACTT-1 trial, which demonstrated faster recovery times than before. reported for the treatment of adults hospitalized with mild to moderate or severe coronavirus cases. Remdesivir has also been shown to reduce the progression of the disease in critically ill patients who need oxygen.
However, on Friday, a WHO panel advised against using remdesivir in hospitalized patients with coronavirus, citing “little to no effect” in patients following a multi-country solidarity trial. Gilead disputed these allegations.
Fox News’ Alexandria Hein and Lucas Manfredi contributed to this report.
GET THE FOX NEWS APP
[ad_2]
Source link