FDA broadens existing emergency use of Lilly and Incyte's baricitinib in patients hospitalized with COVID-19 requiring oxygen
"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
The FDA based today's decision on data from the Phase 3 COV-BARRIER study, announced
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
"Recent clinical data have helped improve our understanding of the potential role of baricitinib in the treatment of certain hospitalized patients with COVID-19 and the broadened EUA represents a critical step in fighting the pandemic," said
The FDA grants emergency use authorization to provide availability of a medicine that may help diagnose, treat or prevent a life-threatening disease when no adequate and approved alternatives are available. This use of baricitinib is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use, unless the declaration is terminated or authorization revoked sooner. The authorization is temporary and does not replace the formal review and approval process. In the U.S., baricitinib has not been approved by the FDA to treat COVID-19, and the efficacy, safety and optimal duration of treatment of baricitinib for COVID-19 has not been established. Evaluation of baricitinib's efficacy and safety as a treatment for COVID-19 is ongoing in clinical trials. Essential safety information on the authorized emergency use of baricitinib includes warnings related to serious infections, thrombosis, abnormal laboratory values, vaccinations and hypersensitivity. Serious side effects observed in COVID-19 patients include serious venous thrombosis and serious infections. Additional safety information can be viewed below.
In December 2020, Lilly initiated an addendum to the COV-BARRIER study to evaluate baricitinib in mechanically ventilated patients (ordinal scale 7) at baseline. The study is currently ongoing with data expected in the coming months. In addition, baricitinib is being tested in the
Under the EUA, inpatient pharmacies in the U.S. may order 1-mg and 2-mg tablets of baricitinib through
Baricitinib is an oral JAK inhibitor discovered by
Authorized Use Under the EUA and Important Safety Information for baricitinib (in the
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.
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.
BC HCP EUA ISI 28JUL2021
About OLUMIANT ® (baricitinib)
OLUMIANT, a once-daily, oral JAK inhibitor was discovered by
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
PP-BC-US-0083 07/2021 ©Lilly
View original content to download multimedia:https://www.prnewswire.com/news-releases/fda-broadens-existing-emergency-use-of-lilly-and-incytes-baricitinib-in-patients-hospitalized-with-covid-19-requiring-oxygen-301344355.html