The U.S. Food and Drug Administration (FDA) has granted emergency use authorization (EUA) to Eli Lilly and Company for the use of baricitinib in combination with remdesivir to treat COVID-19 in hospitalized adults and children at least two years of age requiring supplemental oxygen, invasive mechanical ventilation or extracorporeal membrane oxygenation.
FHI Clinical is thrilled to have supported the clinical research efforts during the Adaptive COVID-19 Treatment Trial (ACTT)-2, which produced the evidence for this EUA. The ACTT-2 is a randomized, double-blind, placebo-controlled study conducted by the National Institutes of Health (NIH) National Institute of Allergy and Infectious Diseases (NIAID) to evaluate the efficacy and safety of baricitinib in combination with remdesivir versus placebo with remdesivir in hospitalized patients with moderate or severe COVID-19. Statistically significant better median time to recovery, lower odds of death or ventilation at day 29, and higher odds of clinical improvement at day 15 were observed in the combination treatment group.
Baricitinib, under the brand name Olumiant, is already FDA-approved to treat moderately to severely active rheumatoid arthritis, and remdesivir, under the brand name Veklury, is also FDA-approved as an intravenous antiviral drug to treat COVID-19 during hospitalization for adult and pediatric patients at least 12 years of age. The remdesivir approval was based on the results of the ACTT-1 trial, which FHI Clinical also supported.
For more information about the EUA, read the FDA press release or Eli Lilly and Company press release. For more information about the ACTT-2 trial, visit clinicaltrials.gov, and visit here for more information about the outcomes of the ACTT-1 trial for remdesivir.
