Lilly and Incyte's baricitinib reduced deaths among patients with COVID-19 receiving invasive mechanical ventilation
"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
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
Baricitinib is an oral JAK inhibitor discovered by
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.
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) <1000 cells/mm3, absolute lymphocyte count (ALC) <200 cells/mm3, and hemoglobin <8 g/dL.
Evaluate estimated glomerular filtration rate (eGFR), liver enzymes, and complete blood count at baseline and thereafter according to local patient management practice. Monitor closely when treating patients with abnormal baseline and post-baseline laboratory values. Follow dose adjustments as recommended in the Fact Sheet for Healthcare Providers for patients with abnormal renal, hematological and hepatic laboratory values. Manage patients according to routine clinical guidelines.
Vaccinations: Avoid use of live vaccines with baricitinib.
Hypersensitivity: If a serious hypersensitivity occurs, discontinue baricitinib while evaluating the potential causes of the reaction.
See Warnings and Precautions in the FDA-approved full Prescribing Information and Medication Guide for additional information on risks associated with longer-term treatment with baricitinib.
Serious Side Effects
Serious venous thrombosis, including pulmonary embolism, and serious infections have been observed in COVID-19 patients treated with baricitinib and are known adverse drug reactions of baricitinib.
In the COVID-19 clinical trials, adverse drug reactions in the safety population occurring in ≥ 1% of patients treated with baricitinib were alanine aminotransferase (ALT) ≥3 x upper limit of normal (ULN) (18.0%), aspartate aminotransferase (AST) ≥3 x ULN (11.5%), thrombocytosis >600,000 cells/mm3 (8.2%), creatine phosphokinase (CPK) >5 x ULN (3.7%), neutropenia <1000 cells/mm3 (2.2%), deep vein thrombosis (1.5%), pulmonary embolism (1.4%), and urinary tract infection (1.3%).
Use in Specific Populations
Pregnancy: Baricitinib should be used during pregnancy only if the potential benefit justifies the potential risk for the mother and the fetus.
Renal Impairment: There are limited data for baricitinib in patients with severe renal impairment. Baricitinib is not recommended for patients who are on dialysis, have end-stage renal disease, or have acute kidney injury.
Hepatic Impairment: Baricitinib has not been studied in patients with severe hepatic impairment. Baricitinib should only be used in patients with severe hepatic impairment if the potential benefit outweighs the potential risk.
Please see Fact Sheet for Healthcare Providers and Fact Sheet for Patients, Parents and Caregivers (English) or Fact Sheet for Patients, Parents and Caregivers (Spanish).
BC HCP EUA ISI 28JUL2021
About OLUMIANT ® (baricitinib)
OLUMIANT, a once-daily, oral JAK inhibitor was discovered by
About COV-BARRIER Sub-Study
COV-BARRIER sub-study was a randomized, double-blind, placebo-controlled trial, initiated in
COV-BARRIER was a global, 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 were identified. The study findings from COV-BARRIER have been submitted to a peer-reviewed journal for future print publication.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about OLUMIANT (baricitinib) as a potential treatment for patients with COVID-19 and reflects
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