FDA Issues an EUA for Baricitinib in Combination with Remdesivir for Severe COVID-19

The US Food and Drug Administration issued an emergency use authorization (EUA) for the therapy baricitinib, in combination with remdesivir, for adult and pediatric patients 2 years and older hospitalized with COVID-19 and require either supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation.

“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,” FDA Commissioner Stephen M. Hahn, MD, said. “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.”

Back in October, findings from the ACTT-2 trial, showed remdesivir plus baricitinib was associated with a 35% decrease in mortality versus remdesivir given as a standalone treatment to hospitalized COVID-19 patients.

ACTT-2 is a double-blind, placebo-controlled clinical trial, and followed 1033 patients for 29 days and included people with moderate or severe COVID-19. In the study, 515 patients received baricitinib plus remdesivir, and 518 patients received placebo plus remdesivir.

Recovery was defined as either being discharged from the hospital or being hospitalized but not requiring supplemental oxygen and no longer requiring ongoing medical care. The median time to recovery from COVID-19 was 7 days for baricitinib plus remdesivir and 8 days for placebo plus remdesivir.

The odds of a patient’s condition progressing to death or being ventilated at day 29 was lower in the baricitinib plus remdesivir group versus the placebo plus remdesivir group. The odds of clinical improvement at day 15 was higher in the baricitinib plus remdesivir group versus the placebo plus remdesivir group. For all of these endpoints, the effects were statistically significant.

Last month, remdesivir became the first therapy in the US given FDA approval to treat adults and children 12 years and older with COVID-19 who require hospitalization.

The therapy baricitinib is a janus kinase inhibitor, which blocks the activity of one or more of a specific family of enzymes, interfering with the pathway that leads to inflammation. Baricitinib is a prescription oral tablet medication that is FDA approved for the treatment of moderately to severely active rheumatoid arthritis.