FDA Authorizes Arthritis Drug Combo for COVID-19
November 19, 2020 – The FDA on Thursday granted emergency use authorization for the arthritis drug baricitinib for use in combination with remdesivir to treat adults and children hospitalized with suspected or confirmed COVID-19.
The suit is intended for patients who require supplemental oxygen or mechanical ventilation.
Baricitinib plus remdesivir was shown in a clinical trial to reduce recovery time within 29 days of starting treatment, compared to a control group given placebo plus remdesivir, according to the FDA press release.
The median time to recovery from COVID-19 was 7 days for the combined group versus 8 days for those in the placebo plus remdesivir group. Recovery was defined as either being discharged from the hospital or “being hospitalized but not requiring supplemental oxygen and no longer requiring continued medical attention,” the agency said.
The likelihood of a patient dying or needing a ventilator on day 29 was lower in the combined group compared to those taking placebo and remdesivir, although no specific data was provided. “For all of these parameters, the effects were statistically significant,” the agency said.
Emergency use authorization allows doctors to use the drugs during a health crisis. Full approval takes significantly longer, and research continues.
“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 Said Patrizia Cavazzoni, MD, acting director of the FDA’s Center for Drug Evaluation and Research.
“Despite the progress made in managing COVID-19 infection since the onset of the pandemic, we need more therapies to accelerate recovery and further clinical research will be essential to identify therapies that slow the progression disease and reduce mortality in the sickest patients, ”she said. .
The data justifying the request for authorization are based on a randomized, double-blind, placebo-controlled clinical trial conducted by the National Institute of Allergy and Infectious Diseases.
The trial followed patients for 29 days and included 1,033 patients with moderate to severe COVID-19. In the study, 515 patients received baricitinib plus remdesivir and 518 patients received placebo plus remdesivir.
Upon reviewing the association, the FDA “has determined that it is reasonable to believe that baricitinib, in combination with remdesivir, may be effective in the treatment of COVID-19 in the licensed population” and the known benefits outweigh on known and potential risks. In addition, there are no adequate, approved and available alternatives for the treated population.
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