Eli Lilly and Company (NYSE: LLY) and Incyte (NASDAQ:INCY) announced today the U.S. Food and Drug Administration (FDA) has broadened the Emergency Use Authorization (EUA) for baricitinib to allow for treatment with or without remdesivir, whereas the EUA was previously restricted to use only in combination with remdesivir. The EUA now provides for the use of baricitinib for treatment of COVID-19 in hospitalized adults and pediatric patients two years of age or older requiring supplemental oxygen, non-invasive or invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO).
"Baricitinib in combination with remdesivir has already provided many people with a treatment option that could help prevent progression to ventilation or death and increase recovery speed for certain hospitalized patients with COVID-19 under its currently authorized use," said Ilya Yuffa, senior vice president and president of Lilly Bio-Medicines. "Today's FDA action provides physicians additional treatment regimen options for baricitinib to continue to meet the urgent medical needs posed by this pandemic. Based on the increasing body of evidence, we are confident in the potential of baricitinib as an important treatment for the hospitalized COVID-19 patient population requiring supplemental oxygen."
The FDA based today's decision on data from the Phase 3 COV-BARRIER study, announced April 8, 2021. COV-BARRIER was a randomized, double-blind, placebo-controlled study of hospitalized patients comparing baricitinib 4 mg once daily plus standard of care versus placebo plus standard of care. Patients could remain on background standard of care, as defined per local guidelines, including antimalarials, antivirals, corticosteroids, and/or azithromycin. The most frequently used therapies were corticosteroids (79% of patients, mostly dexamethasone) and remdesivir (19% of patients). While the composite primary endpoint of COV-BARRIER, which was defined as a difference in the estimated proportion of participants progressing to non-invasive ventilation including high flow oxygen or invasive mechanical ventilation (including ECMO) or death by Day 28, did not meet statistical significance, baricitinib-treated patients (27.8%) were less likely than those receiving standard of care (30.5%) to progress to ventilation or death (odds ratio [OR]: 0.85; 95% CI: 0.67, 1.08; p=0.180). A pre-specified key secondary endpoint showed baricitinib, in addition to standard of care, meaningfully reduced the risk of death by 39 percent by Day 28 when compared to standard of care alone (n/N: 62/764 [8.1%] baricitinib, 101/761 [13.3%] placebo; [estimated difference in Day 28 probability of mortality = -4.9% (95% CI: -8.0%, -1.9%); hazard ratio [HR] = 0.56 (95% CI: 0.41, 0.77)]. No new safety signals potentially related to the use of baricitinib were identified. The study findings have been submitted to a peer-reviewed journal for future print publication.
The initial EUA was based on data from the Adaptive COVID-19 Treatment Trial (ACTT-2), a randomized double-blind, placebo-controlled study to evaluate the efficacy and safety of baricitinib in combination with remdesivir versus placebo with remdesivir in hospitalized patients with or without oxygen requirements conducted by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). Data supporting the initial EUA included the primary endpoint of median time to recovery, which was seven days for baricitinib plus remdesivir compared to eight days for placebo plus remdesivir (HR: 1.15; 95% CI: 1.00, 1.31; p=0.047). Secondary endpoints included the proportion of patients who died or progressed to non-invasive ventilation/high-flow oxygen or invasive mechanical ventilation by Day 29, which was lower in bari...
(All Rights Reserved)