OLUMIANT is the first and only JAK inhibitor
FDA-approved for the treatment of COVID-19 in certain hospitalized
adults requiring various degrees of oxygen support
INDIANAPOLIS, May 11, 2022
/PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and Incyte
(NASDAQ: INCY) announced today the U.S. Food and Drug
Administration (FDA) has approved OLUMIANT®
(baricitinib) for the treatment of COVID-19 in hospitalized adults
requiring supplemental oxygen, non-invasive or invasive mechanical
ventilation, or extracorporeal membrane oxygenation (ECMO) with a
recommended dose of 4-mg once daily for 14 days or until hospital
discharge, whichever comes first.
"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."
The FDA's approval is supported by results from two randomized,
double-blind, placebo-controlled Phase 3 studies (ACTT-2 and
COV-BARRIER, including the COV-BARRIER OS 7 addendum study),
announced previously. No new safety signals potentially related to
the use of OLUMIANT were identified in the studies.
"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."
Baricitinib has been available in the U.S. under Emergency Use
Authorization (EUA) since November
2020. An EUA will remain in place for hospitalized pediatric
patients 2 to less than 18 years old who require various degrees of
oxygen support. The emergency authorization is not an approval and
is temporary for the duration where circumstances justify the
authorization. For additional information about the authorized use,
please see the FDA Letter of Authorization, Fact Sheet for
Healthcare Providers and Fact Sheet for Patients, Parents and
Caregivers.
Lilly has submitted applications for regulatory approval or
authorization to multiple regulatory agencies around the world and
anticipates further regulatory decisions to follow.
The U.S. FDA-approved labeling for OLUMIANT carries a boxed
warning for risk of serious infections, mortality, malignancy,
major adverse cardiovascular events (MACE) and thrombosis. Patients
treated with OLUMIANT are at an increased risk of serious
bacterial, fungal, viral and opportunistic infections leading to
hospitalization or death, including tuberculosis. Higher rates of
all-cause mortality and MACE have been observed with another JAK
inhibitor versus tumor necrosis factor (TNF) blockers. Malignancies
and thrombosis have occurred in patients treated with OLUMIANT and
higher rates of each have been observed with another JAK inhibitor
versus TNF blockers. Consider the risks and benefits of treatment
prior to initiating or continuing therapy with OLUMIANT. Please
see additional Important Safety Information below.
OLUMIANT is a once-daily, oral JAK inhibitor discovered by
Incyte and licensed to Lilly. To learn more about OLUMIANT, please
visit www.OLUMIANT.com. OLUMIANT is available in the U.S. as 1-mg
and 2-mg tablets through Lilly's authorized specialty
distributors.
About ACTT-2 (COVID I) Study
ACTT-2 was a
randomized, double-blind, placebo-controlled clinical trial of
certain hospitalized adults with confirmed SARS-CoV-2 infection
that compared treatment with OLUMIANT and remdesivir (combination
group; n=515) to treatment with placebo and remdesivir (placebo
group; n=518). Patients treated with the combination received
OLUMIANT 4-mg once daily (orally) for 14 days or until hospital
discharge, whichever was first, and remdesivir 200-mg on Day 1 and
100-mg once-daily (via intravenous infusion) on subsequent days for
a total treatment duration of 10 days or until hospital discharge,
whichever was first.
The primary endpoint, for the intent to treat population, was
time to recovery within 29 days after randomization. Recovery was
defined as being discharged from the hospital without limitations
on activities, being discharged from the hospital with limitations
on activities and/or requiring home oxygen, or hospitalized but not
requiring supplemental oxygen and no longer requiring medical care.
The key secondary endpoint was clinical status on Day 15, as
assessed on an 8-point ordinal scale.
About COV-BARRIER (COVID II)
Study
COV-BARRIER was a randomized,
double-blind, placebo-controlled clinical trial of certain
hospitalized adults with confirmed SARS-CoV-2 infection that
compared treatment with OLUMIANT 4-mg once daily (n=764) with
placebo (n=761). OLUMIANT was administered for 14 days or until
hospital discharge, whichever came first. Patients could remain on
background standard of care, as defined per local guidelines.
Patients requiring invasive mechanical ventilation or ECMO at
baseline were enrolled in an exploratory addendum study of
COV-BARRIER. These patients were not included in the main
COV-BARRIER study population and were analyzed separately.
The primary endpoint was the proportion of patients who died or
progressed to non-invasive ventilation/high-flow oxygen or invasive
mechanical ventilation within the first 28 days of the study.
Patients who required non-invasive ventilation/high-flow oxygen at
baseline needed to worsen by at least 1 point on an 8-point ordinal
scale to progress. A key secondary endpoint was all-cause mortality
by Day 28.
About COV-BARRIER OS 7 Addendum Study
The
COV-BARRIER OS 7 addendum study was an exploratory, randomized,
double-blind, placebo-controlled substudy of COV-BARRIER in certain
hospitalized adults with confirmed SARS-CoV-2 infection requiring
invasive mechanical ventilation or ECMO at baseline. This substudy
compared treatment with OLUMIANT 4-mg once daily + standard of care
(SOC) (n=51) with placebo + SOC (n=50). All patients received SOC
in keeping with local clinical practice for COVID-19 management.
OLUMIANT was administered for 14 days or until hospital discharge,
whichever occurred first. All endpoints in this substudy are
considered exploratory, including the prespecified endpoint of
all-cause mortality by Day 28.
Indication and Usage for OLUMIANT (baricitinib) tablets (in
the United
States)
OLUMIANT is indicated for the treatment of coronavirus disease
2019 (COVID-19) in hospitalized adults requiring supplemental
oxygen, non-invasive or invasive mechanical ventilation, or
extracorporeal membrane oxygenation (ECMO).
IMPORTANT SAFETY INFORMATION FOR OLUMIANT (baricitinib)
tablets
WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR
ADVERSE CARDIOVASCULAR EVENTS, AND THROMBOSIS
SERIOUS INFECTIONS
Patients treated with Olumiant are at risk for developing
serious infections that may lead to hospitalization or death. Most
patients with rheumatoid arthritis (RA) who developed these
infections were taking concomitant immunosuppressants such as
methotrexate or corticosteroids. If a serious infection develops,
interrupt Olumiant until the infection is controlled. Reported
infections include:
- Active tuberculosis (TB), which may present with pulmonary
or extrapulmonary disease. Olumiant should not be given to patients
with active tuberculosis. Test patients, except those with
COVID-19, for latent TB before initiating Olumiant and during
therapy. If positive, start treatment for latent infection prior to
Olumiant use.
- Invasive fungal infections, including candidiasis and
pneumocystosis. Patients with invasive fungal infections may
present with disseminated, rather than localized, disease.
- Bacterial, viral, and other infections due to opportunistic
pathogens.
Carefully consider the risks and benefits of Olumiant prior
to initiating therapy in patients with chronic or recurrent
infection. Closely monitor patients for the
development of signs and symptoms of infection during and after
treatment with Olumiant including the possible development of TB in
patients who tested negative for latent TB infection prior to
initiating therapy.
The most common serious infections reported with Olumiant
included pneumonia, herpes zoster, and urinary tract infection.
Among opportunistic infections, tuberculosis, multidermatomal
herpes zoster, esophageal candidiasis, pneumocystosis, acute
histoplasmosis, cryptococcosis, cytomegalovirus, and BK virus were
reported with Olumiant. Some patients have presented with
disseminated rather than localized disease, and were often taking
concomitant immunosuppressants such as methotrexate or
corticosteroids.
Avoid use of Olumiant in patients with an active, serious
infection, including localized infections. Consider the risks and
benefits of treatment prior to initiating Olumiant in patients:
with chronic or recurrent infection; who have been exposed to TB;
with a history of a serious or an opportunistic infection; who have
resided or traveled in areas of endemic tuberculosis or endemic
mycoses; or with underlying conditions that may predispose them to
infection.
The risks and benefits of treatment with Olumiant in COVID-19
patients with other concurrent infections should be considered.
Consider anti-TB therapy prior to initiation of Olumiant in
patients with a history of latent or active TB in whom an adequate
course of treatment cannot be confirmed, and for patients with a
negative test for latent TB but who have risk factors for TB
infection.
Viral reactivation, including cases of herpes virus reactivation
(e.g., herpes zoster), were reported in clinical studies with
Olumiant. If a patient develops herpes zoster, interrupt Olumiant
treatment until the episode resolves. The impact of Olumiant on
chronic viral hepatitis reactivation is unknown. Screen for viral
hepatitis in accordance with clinical guidelines before initiating
Olumiant.
MORTALITY
In a large, randomized, postmarketing safety study in RA
patients 50 years of age and older with at least one cardiovascular
risk factor comparing another Janus kinase (JAK) inhibitor to tumor
necrosis factor (TNF) blockers, a higher rate of all-cause
mortality, including sudden cardiovascular death, was observed with
the JAK inhibitor.
Consider the benefits and risks for the individual patient prior
to initiating or continuing therapy with Olumiant.
MALIGNANCIES
Lymphoma and other malignancies have been observed in patients
treated with Olumiant. In RA patients treated with another JAK
inhibitor, a higher rate of malignancies (excluding non-melanoma
skin cancer [NMSC]) was observed when compared with TNF blockers.
Patients who are current or past smokers are at additional
increased risk. A higher rate of lymphomas was observed in
patients treated with the JAK inhibitor compared to those treated
with TNF blockers. A higher rate of lung cancers and an additional
increased risk of overall malignancies were observed in current or
past smokers treated with the JAK inhibitor compared to those
treated with TNF blockers.
Consider the benefits and risks for the individual patient prior
to initiating or continuing therapy with Olumiant, particularly in
patients with a known malignancy (other than successfully treated
NMSC), patients who develop a malignancy, and patients who are
current or past smokers.
NMSCs have been reported in patients treated with Olumiant.
Periodic skin examination is recommended for patients who are at
increased risk for skin cancer.
MAJOR ADVERSE CARDIOVASCULAR EVENTS
In RA patients 50 years of age and older with at least one
cardiovascular risk factor treated with another JAK inhibitor, a
higher rate of major adverse cardiovascular events (MACE) (defined
as cardiovascular death, myocardial infarction [MI], and stroke)
was observed when compared with TNF blockers. Patients who are
current or past smokers are at additional increased risk.
Discontinue Olumiant in patients that have experienced a myocardial
infarction or stroke.
Consider the benefits and risks for the individual patient prior
to initiating or continuing therapy with Olumiant, particularly in
patients who are current or past smokers and patients with other
cardiovascular risk factors. Inform patients about the symptoms of
serious cardiovascular events and the steps to take if they
occur.
THROMBOSIS
Thrombosis, including deep venous thrombosis (DVT) and pulmonary
embolism (PE), has been observed at an increased incidence in
patients treated with Olumiant compared to placebo. In addition,
there were cases of arterial thrombosis. Many of these adverse
events were serious and some resulted in death. In RA patients 50
years of age and older with at least one cardiovascular risk factor
treated with another JAK inhibitor, a higher rate of thrombosis was
observed when compared with TNF blockers. Avoid Olumiant in
patients at risk. Discontinue Olumiant and promptly evaluate
patients with symptoms of thrombosis.
GASTROINTESTINAL PERFORATIONS
Gastrointestinal perforations have been reported in Olumiant
clinical studies, although the role of JAK inhibition in these
events is not known. Monitor Olumiant-treated patients who may be
at increased risk for gastrointestinal perforation (e.g., patients
with a history of diverticulitis). Promptly evaluate patients who
present with new onset abdominal symptoms for early identification
of gastrointestinal perforation.
LABORATORY ABNORMALITIES
Neutropenia – Olumiant treatment was associated
with an increased incidence of neutropenia (absolute neutrophil
count [ANC] <1000 cells/mm3) compared to placebo.
Evaluate at baseline and thereafter according to routine patient
management.
In patients with RA, avoid initiation or interrupt Olumiant
treatment in patients with an ANC <1000 cells/mm3. In
patients with COVID-19, avoid initiation or interrupt Olumiant
treatment in patients with an ANC <500 cells/mm3.
Lymphopenia – Absolute lymphocyte count (ALC)
<500 cells/mm3 were reported in Olumiant clinical
trials. Lymphocyte counts less than the lower limit of normal were
associated with infection in patients treated with Olumiant, but
not placebo. Evaluate at baseline and thereafter according to
routine patient management.
In patients with RA, avoid initiation or interrupt Olumiant
treatment in patients with an ALC <500 cells/mm3. In
patients with COVID-19, avoid initiation or interrupt Olumiant
treatment in patients with an ANC <200 cells/mm3.
Anemia – Decreases in hemoglobin levels to
<8 g/dL were reported in Olumiant clinical trials. Evaluate at
baseline and thereafter according to routine patient
management.
In patients with RA, avoid initiation or interrupt Olumiant
treatment in patients with hemoglobin <8 g/dL. In patients with
COVID-19, there is limited information regarding use of Olumiant in
patients with hemoglobin less than 8 g/dL.
Liver Enzyme Elevations – Olumiant treatment
was associated with increased incidence of liver enzyme elevation
compared to placebo. Increases of alanine transaminase (ALT) ≥5x
upper limit of normal (ULN) and increases of aspartate transaminase
(AST) ≥10x ULN were observed in patients in Olumiant clinical
trials.
Evaluate at baseline and thereafter according to routine patient
management. Promptly investigate the cause of liver enzyme
elevation to identify potential cases of drug-induced liver injury.
If increases in ALT or AST are observed and drug-induced liver
injury is suspected, interrupt Olumiant until this diagnosis is
excluded.
Lipid Elevations – Treatment with Olumiant
was associated with increases in lipid parameters, including total
cholesterol, low-density lipoprotein cholesterol, and high-density
lipoprotein cholesterol. Assess lipid parameters approximately 12
weeks following Olumiant initiation in patients with RA. Manage
patients according to clinical guidelines for the management of
hyperlipidemia.
VACCINATIONS
Avoid use of live vaccines with Olumiant. Update immunizations in
patients with rheumatoid arthritis prior to initiating Olumiant
therapy in agreement with current immunization
guidelines.
HYPERSENSITIVITY
Reactions such as angioedema, urticaria, and rash that may reflect
drug hypersensitivity have been observed in patients receiving
Olumiant, including serious reactions. If a serious
hypersensitivity reaction occurs, promptly discontinue Olumiant
while evaluating the potential causes of the
reaction.
ADVERSE REACTIONS
In COVID-19 trials, the most common adverse reactions (≥1%)
reported with Olumiant were: ALT ≥3x ULN, AST ≥3x ULN,
thrombocytosis (platelets >600,000 cells/mm3),
creatine phosphokinase >5x ULN, neutropenia (ANC <1000
cells/mm3), DVT, PE, and urinary tract infection.
PREGNANCY AND LACTATION
Limited data on Olumiant use in pregnant women are not sufficient
to inform a drug-associated risk for major birth defects or
miscarriage. Advise women with RA not to breastfeed during
treatment with Olumiant.
HEPATIC AND RENAL IMPAIRMENT
Olumiant should only be used in patients with COVID-19 and severe
hepatic impairment if the potential benefit outweighs the potential
risk. Olumiant is not recommended in patients with COVID-19 who are
on dialysis, have end-stage renal disease or with eGFR <15
mL/min/1.73m2.
Please click to access full Prescribing
Information, including Boxed Warning about Serious
Infections, Mortality, Malignancy, Major Adverse Cardiovascular
Events, and Thrombosis, and Medication
Guide.
BA HCP ISI COV 11MAY2022
About OLUMIANT®
OLUMIANT, a once-daily,
oral JAK inhibitor, was discovered by Incyte and licensed to Lilly.
It is approved in the U.S. and more than 75 countries as a
treatment for adults with moderate to severe rheumatoid arthritis.
Marketing authorization for the treatment of hospitalized patients
with COVID-19 and approval has been granted for OLUMIANT in
multiple countries. To date, nearly one million patients worldwide
with COVID-19 have been treated with OLUMIANT (baricitinib). The
U.S. FDA-approved labeling for OLUMIANT includes a Boxed Warning
for Serious Infections, Mortality, Malignancy, Major Adverse
Cardiovascular Events, and Thrombosis. See the full Prescribing
Information here.
In December 2009, Lilly and Incyte
announced an exclusive worldwide license and collaboration
agreement for the development and commercialization of OLUMIANT and
certain follow-on compounds for patients with inflammatory and
autoimmune diseases.
About Lilly
Lilly unites caring with discovery to create medicines that make
life better for people around the world. We've been pioneering
life-changing discoveries for nearly 150 years, and today our
medicines help more than 47 million people across the globe.
Harnessing the power of biotechnology, chemistry and genetic
medicine, our scientists are urgently advancing new discoveries to
solve some of the world's most significant health challenges,
redefining diabetes care, treating obesity and curtailing its most
devastating long-term effects, advancing the fight against
Alzheimer's disease, providing solutions to some of the most
debilitating immune system disorders, and transforming the most
difficult-to-treat cancers into manageable diseases. With each step
toward a healthier world, we're motivated by one thing: making life
better for millions more people. That includes delivering
innovative clinical trials that reflect the diversity of our world
and working to ensure our medicines are accessible and affordable.
To learn more,
visit Lilly.com and Lilly.com/newsroom or
follow us on Facebook, Instagram, Twitter and
LinkedIn. P-LLY
About Incyte
Incyte is a Wilmington, Delaware-based, global
biopharmaceutical company focused on finding solutions for serious
unmet medical needs through the discovery, development and
commercialization of proprietary therapeutics. For additional
information on Incyte, please visit Incyte.com and follow
@Incyte.
OLUMIANT® is a registered trademark owned or licensed
by Eli Lilly and Company, its subsidiaries, or affiliates.
Lilly 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 treatment for patients with
COVID-19 and reflects Lilly's and Incyte's current beliefs and
expectations. However, as with any pharmaceutical product, there
are substantial risks and uncertainties in the process of drug
research, development, and commercialization. Among other things,
there can be no guarantee that planned or ongoing studies will be
completed as planned, that future study results will be consistent
with the results to date, and that OLUMIANT will receive additional
regulatory approvals, or be commercially successful. For further
discussion of these and other risks and uncertainties, see Lilly's
and Incyte's most recent respective Form 10-K and Form 10-Q filings
with the United States Securities and Exchange Commission. Except
as required by law, Lilly and Incyte undertake no duty to update
forward-looking statements to reflect events after the date of this
release.
PP-BA-US-1705 05/2022 © Lilly USA, LLC 2022. All rights reserved.
Refer
to:
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Rachel
Sorvig; sorvig_rachel@lilly.com; +1-317-607-7507
(Lilly media)
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|
Kevin Hern;
hern_kevin_r@lilly.com; +1-317-277-1838 (Lilly
investors)
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|
Catalina Loveman;
cloveman@incyte.com; +1-302-498-6171 (Incyte media)
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Christine Chiou;
cchiou@incyte.com; +1-302-274-4773 (Incyte investors)
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