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For managing COVID-19 infected
patients, US-FDA has granted emergency use authorization (EUA) to baricitinib
and remdesivir combination.
On 19th November 2020, the United States Food and Drug Administration (US-FDA) published a EUA for baricitinib/remdesivir combination for treating suspected or lab confirmed coronavirus disease 2019 (COVID-19) in hospitalized adult patients and pediatrics aged two years or older needing extracorporeal membrane oxygenation (ECMO), invasive mechanical ventilation, or supplemental oxygen.
Baricitinib (a janus kinase inhibitor), in combination with remdesivir (antiviral drug), was found to minimize time to recovery within 29 days after starting therapy in comparison with subjects who were given a placebo with remdesivir.
The EUA was granted based on the data from a randomized, placebo-controlled double-blind (ACTT-2) study. This trial carried out by the National Institute of Allergy and Infectious Diseases (NIAID) aimed to explore the efficacy and safety of baricitinib plus remdesivir, in 1033 patients having moderate to severe COVID-19. The participants were followed for 29 days.
Participants were randomly allocated to receive baricitinib plus remdesivir (n=515) or placebo plus remdesivir (n=518). The primary outcome parameter was the time to recovery, defined as subjects being hospitalized but no longer needing supplemental oxygen or ongoing medical assistance in the hospital, or the patient being discharged from the hospital.
The median time to recovery from COVID-19 was less for the baricitinib/remdesivir group compared to the placebo/remdesivir group, as shown in the following table:
Compared to the placebo/remdesivir arm, the odds of an individual’s condition progressing to mortality or being ventilated at day 29 was found to be reduced in the baricitinib/remdesivir arm. Compared to the placebo/remdesivir arm, the odds of clinical improvement at the 15th day was found to be greater in the baricitinib/remdesivir arm. For all these endpoints, the effects illustrated statistical significance.
The possible treatment-emergent adverse effects include allergic reactions, serious infections, changes in certain lab test results, and blood clots. The FDA’s EUA of this combo depicts a progressive step in treating hospitalized COVID-19 patients, and the FDA’s foremost authorization of a therapeutic agent that potentially acts on the inflammation pathway.
The efficacy and safety of this investigational treatment for use in combating
COVID-19 continue to be assessed. Baricitinib is not authorized as a stand-alone
management option for combating COVID-19. Thus, a combination of baricitinib
and remdesivir appears to yield satisfactory results in COVID-19 infected
patients.
US FDA
Coronavirus (COVID-19) Update: FDA Authorizes Drug Combination for Treatment of COVID-19
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