Nov. 19, 2020 — The FDA on Thursday granted emergency use authorization for the arthritis drug baricitinib to be used in combination with remdesivir to treat hospitalized adults and children with suspected or confirmed COVID-19.
The combination is meant for patients who need supplemental oxygen or mechanical ventilation.
Baricitinib plus remdesivir was shown in a clinical trial to reduce recovery time within 29 days of starting the treatment, compared with a control group who received placebo plus remdesivir, according to the FDA press release.
The median time to recovery from COVID-19 was 7 days for the combination group vs. 8 days for those in the placebo plus remdesivir group. Recovery was defined as either discharge from the hospital or “being hospitalized but not requiring supplemental oxygen and no longer requiring ongoing medical care,” the agency said.
The odds of a patient dying or needing a ventilator at day 29 was lower in the combination group compared with those taking placebo and remdesivir, although no specific data was provided. “For all of these endpoints, the effects were statistically significant,” the agency stated.
Emergency use authorization allows doctors to use the drugs during a health crisis. Full approval takes much longer, and the research continues.
“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,” said Patrizia Cavazzoni, MD, acting director of the FDA’s Center for Drug Evaluation and Research.
“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,” she said.
The data supporting the authorization requrest is 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.
In reviewing the combination, the FDA “determined that it is reasonable to believe that baricitinib, in combination with remdesivir, may be effective in treating COVID-19 for the authorized population” and the known benefits outweigh the known and potential risks. Additionally, there are no adequate, approved, and available alternatives for the treatment population.