- New data from Phase 3 COV-BARRIER sub-study indicates one death prevented for every six baricitinib-treated patients on mechanical ventilation or ECMO compared to placebo
- Data showed 46% risk reduction in mortality by Day 28 and 44% risk reduction in mortality by Day 60
INDIANAPOLIS, Aug. 3, 2021 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and Incyte (NASDAQ:INCY) announced today results from an additional cohort of 101 adult patients from the COV-BARRIER trial. In this sub-study, patients with COVID-19 on mechanical ventilation or extracorporeal membrane oxygenation (ECMO) who received baricitinib plus standard of care were 46 percent less likely to die by Day 28 compared to patients who received placebo plus standard of care (nominal p-value=0.0296; hazard ratio [HR] [95% CI] = 0.54 [0.31, 0.96]; analysis not adjusted for multiplicity). The cumulative proportion of patients who died by Day 28 was 39.2 percent (n/N: 20/51) in the baricitinib arm versus 58 percent in the placebo arm (n/N: 29/50). Similar mortality benefit was observed by Day 60 (HR [96% CI] = 0.56 [0.33, 0.97]) with a cumulative proportion of death of 45.1 percent (n/N: 23/51) for baricitinib compared to 62.0 percent for placebo (n/N: 31/50). These findings are consistent with the reduction in mortality observed in the overall COV-BARRIER patient population.
"As additional data from COV-BARRIER become available, it is increasingly evident that treatment with baricitinib may help prevent death in some of the most critically ill COVID-19 patients and that baricitinib represents an important treatment option for this vulnerable group of patients in this constantly evolving pandemic," said E. Wesley Ely, M.D., M.P.H., professor of medicine and co-director of the Critical Illness, Brain Dysfunction, and Survivorship (CIBS) Center at Vanderbilt University Medical Center and co-principal investigator of COV-BARRIER.
By Day 28, the frequency of adverse events, serious adverse events and serious infections were similar in the baricitinib group (88%, 50% and 44%, respectively) compared to placebo (95.9%, 71.4% and 53.1%, respectively). Venous thromboembolic events were reported in 6 percent of patients treated with baricitinib and 6.1 percent of patients treated with placebo. No new safety signals were identified.
"In the interest of public health and safety, it remains a priority to provide healthcare professionals with as much information as possible about treatment options that may help improve outcomes for patients with severe disease," said Ilya Yuffa, senior vice president and president of Lilly Bio-Medicines. "These new data add to the growing body of evidence demonstrating the important role baricitinib has and may continue to play for certain hospitalized patients with COVID-19."
Lilly intends to publish detailed results from this additional sub-study in a peer-reviewed journal and present the findings at a medical meeting in the coming months. These new data from the COV-BARRIER sub-study will also be shared with regulatory authorities in the U.S., European Union and other geographies.
On July 28, 2021, the U.S. Food and Drug Administration (FDA) broadened the Emergency Use Authorization (EUA) for baricitinib to allow for treatment with or without remdesivir. The EUA 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 ECMO. For more information about the authorized use of baricitinib in COVID-19 and mandatory requirements of the EUA, please see the FDA Letter of Authorization, Fact Sheet for Healthcare Providers and Fact Sheet for Patients, Parents and Caregivers (English) (Spanish).
Baricitinib is an oral JAK inhibitor discovered by Incyte and licensed to Lilly.
Authorized Use Under the EUA and Important Safety Information for baricitinib (in the United States) for COVID-19
Baricitinib is authorized for use under an Emergency Use Authorization (EUA) for treatment of COVID-19 in hospitalized adults and pediatric patients 2 years of age or older requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
Baricitinib has not been approved for the treatment of COVID-19, but has been authorized for emergency use by the FDA. Baricitinib is authorized under an EUA only for the duration of the declaration that circumstances exist justifying the authorization of the EUA of baricitinib under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization revoked sooner.
For more information about the authorized use of baricitinib in COVID-19 and mandatory requirements of the EUA, please see the FDA Letter of Authorization, Fact Sheet for Healthcare Providers and Fact Sheet for Patients, Parents and Caregivers (English) (Spanish).
Important Safety Information about baricitinib for COVID-19 The following provides essential safety information on the unapproved use of baricitinib under the Emergency Use Authorization.
Warnings
Serious Infections: There is limited information regarding use of baricitinib in patients with COVID-19 and concomitant active serious infections.
Serious infections have occurred in patients receiving baricitinib. Avoid the use of baricitinib with known active tuberculosis. Consider if the potential benefits outweigh the potential risks of baricitinib treatment in patients with active serious infections other than COVID-19 or chronic/recurrent infections.
Thrombosis: In hospitalized patients with COVID-19, prophylaxis for venous thromboembolism is recommended unless contraindicated. If clinical features of deep vein thrombosis or pulmonary embolism occur, patients should be evaluated promptly and treated appropriately.
Abnormal Laboratory Values: There is limited information regarding use of baricitinib in patients with COVID-19 and any of the following clinical findings: absolute neutrophil count (ANC)