The Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for baricitinib, in combination with remdesivir, for the treatment of suspected or laboratory confirmed coronavirus disease 2019 (COVID-19) in hospitalized adults and pediatric patients aged 2 years or older requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
The EUA was granted based on data from the randomized, double-blind, placebo-controlled phase 3 ACTT-2 trial, which was conducted by the National Institute of Allergy and Infectious Disease (NIAID). The trial evaluated the efficacy and safety of baricitinib, a Janus kinase inhibitor, plus remdesivir, in 1033 patients with moderate to severe COVID-19 who had either a need for supplemental oxygen, abnormal chest X-ray, or illness requiring mechanical ventilation.
Patients were randomized 1:1 to receive baricitinib 4mg (for up to 14 days of treatment) plus intravenous (IV) remdesivir (for up to 10 days of treatment) or placebo plus IV remdesivir; if necessary, baricitinib was crushed and given through a nasogastric tube. The primary end point was the time to recovery, defined as a patient no longer requiring supplemental oxygen or ongoing medical care in the hospital, or was no longer hospitalized at day 29. Patient outcomes at day 15 were also evaluated as a key secondary outcome measure using an ordinal 8-point scale ranging from fully recovered to death.
Results showed that patients treated with baricitinib plus remdesivir had a median time to recovery of 7 days compared with 8 days for placebo plus remdesivir. Additionally, the baricitinib plus remdesivir treatment arm had lower odds of a patient’s condition progressing to death or being ventilated at day 29 compared with remdesivir alone. The odds of clinical improvement at day 15 were also higher in the baricitinib plus remdesivir arm. For all of these end points, the effects were statistically significant.
“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.
Remdesivir is marketed under the brand name Veklury (Gilead Sciences) and has recently received FDA approval in October 2020 for use in adult and pediatric patients aged 12 years and older and weighing at least 40kg for the treatment of COVID-19 requiring hospitalization. Baricitinib is currently marketed under the brand name Olumiant (Eli Lilly) for the treatment of rheumatoid arthritis (RA).
For more information visit fda.gov.
Coronavirus (COVID-19) update: FDA authorizes drug combination for treatment of COVID-19. [press release]. Silver Spring, MD: US Food and Drug Administration; November 19, 2020.