Approval Announcement
INDIANAPOLIS, May 11, 2022 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and Incyte (NASDAQ: INCY) announced that the U.S. Food and Drug Administration (FDA) has approved Olumiant (baricitinib) for the treatment of COVID-19 in specific hospitalized adult patients.
Indicated Patient Population
Hospitalized adults with COVID-19 who require:
Supplemental oxygen
Non-invasive mechanical ventilation
Invasive mechanical ventilation
Extracorporeal membrane oxygenation (ECMO)
Recommended Dose
4 mg once daily for 14 days or until hospital discharge, whichever comes first.
Expert Commentary
"More than two years into the pandemic, COVID-19 is still hospitalizing many people and burdening our healthcare system. I'm grateful to have Olumiant as a treatment option for those who require various degrees of respiratory support, from supplemental oxygen to mechanical ventilation or ECMO," said Andre Kalil, M.D., M.P.H., Professor of Medicine at the University of Nebraska Medical Center and principal investigator of the Adaptive COVID-19 Treatment Trial 2 (ACTT-2) sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).
"I'm encouraged by the FDA's full approval of Olumiant for the treatment of these patients based on results from the rigorous, placebo-controlled, double-blind, randomized trials. While there are therapies currently available, there is still an urgent need for more options to help improve outcomes for patients hospitalized due to COVID-19."
Basis for Approval: Clinical Trial Data
The FDA’s approval is supported by results from two randomized, double-blind, placebo-controlled Phase 3 studies:
Adaptive COVID-19 Treatment Trial 2 (ACTT-2)
COV-BARRIER study (including the COV-BARRIER OS 7 addendum study)
No new safety signals potentially related to Olumiant use were identified in these studies.
Corporate Statement
"Nearly one million people with COVID-19 have been treated with Olumiant (baricitinib) in approximately 15 countries worldwide," said Patrik Jonsson, Lilly senior vice president, president of Lilly Immunology and Lilly USA, and chief customer officer. "Today's full approval reflects both our confidence in Olumiant's role in treating these hospitalized patients and Lilly's tireless efforts to support the medical community and patients in the ongoing fight against COVID-19."
Emergency Use Authorization (EUA) Status
Prior EUA: Baricitinib has been available in the U.S. under EUA since November 2020.
Current EUA: The EUA remains in place for hospitalized pediatric patients aged 2 to less than 18 years who require various degrees of oxygen support.
EUA Notes: The emergency authorization is not a full approval and is temporary, valid only for the duration of circumstances justifying the authorization.
Additional Information: For details on the authorized use, refer to the FDA Letter of Authorization, Fact Sheet for Healthcare Providers, and Fact Sheet for Patients, Parents and Caregivers.
Global Regulatory Status
Lilly has submitted applications for regulatory approval or authorization to multiple regulatory agencies worldwide and expects further regulatory decisions to follow.
Safety Warnings
The U.S. FDA-approved labeling for Olumiant includes a boxed warning for the following risks:
Serious infections
Mortality
Malignancy
Major adverse cardiovascular events (MACE)
Thrombosis
Key Safety Considerations
Patients treated with Olumiant have an increased risk of serious bacterial, fungal, viral, and opportunistic infections that may lead to hospitalization or death (including tuberculosis).
Higher rates of all-cause mortality and MACE have been observed with another JAK inhibitor compared to tumor necrosis factor (TNF) blockers.
Malignancies and thrombosis have occurred in patients treated with Olumiant; higher rates of both have been observed with another JAK inhibitor versus TNF blockers.
The risks and benefits of Olumiant treatment should be carefully considered before initiating or continuing therapy.
