On Thursday, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the drug called baricitinib (Olumiant) along with remdesivir (Veklury) for the treatment of COVID-19 in hospitalized patients who are above 2 years of age.
Baricitinib, developed by Eli Lily, is a once-a-day pill recommended for the treatment of moderate to severe active rheumatoid arthritis (RA) in adults.
Remdesivir, developed by Gilead Sciences, has recently been approved for the treatment of COVID-19 infection, although the drug was originally developed for Ebola.
The combination of baricitinib and remdesivir is approved for patients who require mechanical ventilation, supplemental oxygen, or extracorporeal membrane oxygenation (ECMO).
In a clinical trial, the combination of these drugs has been shown to reduce the median recovery time by 7 days of initiating the treatment compared to 8 days who received placebo and remdesivir, according to the FDA.
The agency explained, “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 risk of dying or being ventilated at day 29 was reduced among patients who received both baricitinib and remdesivir. The FDA stated, “For all of these endpoints, the effects were statistically significant.”
The agency continues to assess the safety and efficacy of this combination therapy. It is important to note that baricitinib alone is not approved by the FDA for COVID-19 patients.
Dr. Patrizia Cavazzoni, Acting Director of the FDA’s Center for Drug Evaluation and Research, said, “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.”
“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 added.
However, the FDA has emphasized that EUA is not full FDA approval.
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.”
FDA Commissioner Dr. Stephen Hahn said, “Today’s action demonstrates the FDA’s steadfast efforts to make potential COVID-19 treatments available in a timely manner, where appropriate, while continuing to support research to further evaluate whether they are safe and effective.”
“As part of our Coronavirus Treatment Acceleration Program, the FDA continues to use every possible avenue to facilitate new treatments for patients as quickly as possible to combat COVID-19,” he added. The article originally appeared on Medscape Medical News.