INDIANAPOLIS, June 1, 2018 /PRNewswire/ -- Eli Lilly and
Company (NYSE: LLY) and Incyte Corporation (NASDAQ: INCY) announced
today that the U.S. Food and Drug Administration (FDA) has approved
the 2-mg dose of OLUMIANT® (baricitinib), a once-daily
oral medication for the treatment of adults with
moderately-to-severely active rheumatoid arthritis (RA) who have
had an inadequate response to one or more tumor necrosis factor
(TNF) inhibitor therapies.1 Use of OLUMIANT in
combination with other Janus kinase (JAK) inhibitors or biologic
disease-modifying antirheumatic drugs (bDMARDs), or with potent
immunosuppressants such as azathioprine and cyclosporine is not
recommended.1 OLUMIANT may be used as monotherapy or in
combination with methotrexate (MTX) or other non-biologic
DMARDs.1
"We are pleased to provide RA patients in the U.S. an effective
treatment option with OLUMIANT, as people with RA who have had an
inadequate response to TNF inhibitors are generally considered to
be some of the most difficult to treat RA patients," said
Christi Shaw, president, Lilly
Bio-Medicines.
The OLUMIANT clinical trial program included the RA-BEACON
study, a randomized, double-blind, placebo-controlled study in
which patients were randomly assigned to receive OLUMIANT 2 mg,
baricitinib 4 mg or placebo, in addition to conventional DMARDs
that they were currently using.1 This study included 527
patients who had an inadequate response or intolerance to one or
more TNF inhibitor therapies.1 Patients could have had
prior therapy with other bDMARDs.1
The study results showed that significantly higher ACR20
response rates and improvement in all individual ACR20 component
scores were observed at Week 12 with OLUMIANT.1 The
study found that patients treated with OLUMIANT had significantly
higher rates of ACR20 response versus placebo-treated patients at
Week 12 (49% of OLUMIANT-treated patients versus 27% of
placebo-treated patients).1 OLUMIANT also demonstrated
early symptom relief, with ACR20 responses seen as early as Week
1.1 Patients treated with OLUMIANT reported significant
improvements in physical function based on the Health Assessment
Questionnaire Disability Index (HAQ-DI) (recording an average score
of 1.71 before treatment and 1.31 at Week 12) compared to
placebo-treated patients (who recorded an average score of 1.78
before treatment and 1.59 at Week 12).1
OLUMIANT is approved with a Boxed Warning for the risk of
serious infections, malignancies and thrombosis.1
Serious infections leading to hospitalization or death, including
tuberculosis and bacterial, invasive fungal, viral, and other
opportunistic infections, have occurred in patients receiving
OLUMIANT.1 Lymphoma and other malignancies have been
observed in patients treated with OLUMIANT as well.1
Additionally, thrombosis, including deep venous thrombosis,
pulmonary embolism and arterial thrombosis, some fatal, have
occurred in patients treated with OLUMIANT.1 Other
warnings and precautions include gastrointestinal perforations,
laboratory abnormalities (including neutropenia, lymphopenia,
anemia, liver enzyme elevations, and lipid elevations) and a
warning against the use of live vaccines with OLUMIANT.1
The most common adverse events (occurring in greater than or equal
to 1% of OLUMIANT 2 mg- and baricitinib 4 mg-treated patients in
placebo-controlled trials) included upper respiratory tract
infections, nausea, herpes simplex and herpes zoster.1
See Important Safety Information including Boxed Warning below.
As part of the approval, the companies have agreed to conduct a
randomized controlled clinical trial to evaluate the long-term
safety of baricitinib in patients with rheumatoid arthritis.
"Despite the advancements we've seen in the RA treatment
landscape over the past several decades, many patients are still
failing to achieve their disease management goals," said
Seth Ginsberg, co-founder and
president of CreakyJoints and the Global Healthy Living Foundation.
"As it's important for RA patients to have multiple treatment
options available to best suit their disease characteristics and
experiences, the approval of OLUMIANT is very encouraging for our
community."
RA is a chronic, painful and progressive form of
arthritis.2-3 It is estimated that about two-thirds of
established RA patients will not reach clinical remission with
their first TNF inhibitor therapy, and a significant percentage
will not maintain efficacy as time goes on.4
"In my clinical practice, I continue to see patients who
experience debilitating symptoms and who are waiting for a medicine
that may be right for them," said Elizabeth
L. Perkins, M.D., Rheumatology Care Center, Birmingham, Alabama. "OLUMIANT is an important
option for rheumatologists to help address these patients' unmet
needs."
"RA patients continue to experience unique challenges accessing
the treatments prescribed by their healthcare
providers. Therefore, we are determined to continue our work
with stakeholders to demonstrate value across the healthcare system
so providers have greater choice in prescribing treatments to fit
individual patient needs," said Shaw.
Lilly will launch OLUMIANT in the U.S. by the end of the second
quarter of 2018. The price of OLUMIANT will be 60% less than the
leading TNF inhibitor.5 Lilly will be offering a patient
support program, Olumiant Together™. For more
information about this program, please call 1-844-OLUMIANT.
Incyte is now eligible to receive a $100
million milestone payment from Lilly as a result of the
OLUMIANT approval, which Incyte expects to recognize in the second
quarter of 2018.
Indications and
Usage
OLUMIANT® (baricitinib) is indicated for the treatment
of adult patients with moderately to severely active rheumatoid
arthritis who have had an inadequate response to one or more tumor
necrosis factor (TNF) antagonist therapies. Limitation of Use:
Use of OLUMIANT in combination with other JAK inhibitors, biologic
disease-modifying antirheumatic drugs (DMARDs), or with potent
immunosuppressants such as azathioprine and cyclosporine is not
recommended.
IMPORTANT SAFETY INFORMATION FOR OLUMIANT (baricitinib)
tablets
WARNING: SERIOUS INFECTIONS, MALIGNANCY, AND
THROMBOSIS
SERIOUS INFECTIONS: Patients treated with
OLUMIANT are at risk for developing serious infections that may
lead to hospitalization or death. Most patients 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. Test patients for latent TB before
initiating OLUMIANT and during therapy. Treatment for latent
infection should be considered 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.
MALIGNANCIES: Lymphoma and other malignancies
have been observed in patients treated with OLUMIANT.
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. Patients with symptoms of thrombosis should be promptly
evaluated.
WARNINGS AND PRECAUTIONS
SERIOUS INFECTIONS: 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 local
disease, and were often taking concomitant immunosuppressants such
as methotrexate or corticosteroids. Avoid 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.
Monitor patients for infections during and after OLUMIANT
treatment. Interrupt OLUMIANT if a patient develops a serious
infection, an opportunistic infection, or sepsis. Do not resume
OLUMIANT until the infection is controlled.
Tuberculosis – Before initiating OLUMIANT,
evaluate and test patients for latent or active infection and treat
patients with latent TB with standard antimicrobial therapy.
OLUMIANT should not be given to patients with active TB. Consider
anti-TB therapy prior to initiating 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.
Monitor patients for TB during OLUMIANT treatment.
Viral Reactivation – 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.
MALIGNANCY AND LYMPHOPROLIFERATIVE DISORDERS:
Malignancies were observed in OLUMIANT clinical studies. Consider
the risks and benefits of OLUMIANT prior to initiating therapy in
patients with a known malignancy other than a successfully treated
non-melanoma skin cancer (NMSC) or when considering continuing
OLUMIANT in patients who develop a malignancy. NMSCs were reported
in patients treated with OLUMIANT. Periodic skin examination is
recommended for patients who are at increased risk for skin
cancer.
THROMBOSIS: Thrombosis, including DVT and
PE, has been observed at an increased incidence in OLUMIANT-treated
patients compared to placebo. In addition, arterial thrombosis
events in the extremities have been reported in clinical studies
with OLUMIANT. Many of these adverse events were serious and some
resulted in death. There was no clear relationship between platelet
count elevations and thrombotic events. Use OLUMIANT with caution
in patients who may be at increased risk of thrombosis. If clinical
features of DVT/PE or arterial thrombosis occur, evaluate patients
promptly and treat appropriately.
GASTROINTESTINAL PERFORATIONS: Gastrointestinal
perforations have been reported in OLUMIANT clinical studies,
although the role of JAK inhibition in these events is not known.
Use OLUMIANT with caution in 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. Avoid initiation or interrupt OLUMIANT treatment in
patients with an ANC <1000 cells/mm3. Evaluate
at baseline and thereafter according to routine patient
management.
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. Avoid initiation or interrupt OLUMIANT
treatment in patients with an ALC
<500 cells/mm3. Evaluate at baseline and
thereafter according to routine patient management.
Anemia – Decreases in hemoglobin levels to
<8 g/dL were reported in OLUMIANT clinical trials. Avoid
initiation or interrupt OLUMIANT treatment in patients with
hemoglobin <8 g/dL. Evaluate at baseline and thereafter
according to routine patient management.
Liver Enzyme Elevations – OLUMIANT treatment was
associated with increased incidence of liver enzyme elevation
compared to placebo. Increases to ≥5x and ≥10x upper limit of
normal were observed for both ALT and AST 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. Manage patients
according to clinical guidelines for the management of
hyperlipidemia.
VACCINATIONS: Avoid use of live vaccines with
OLUMIANT. Update immunizations in agreement with current
immunization guidelines prior to initiating OLUMIANT therapy.
ADVERSE REACTIONS
Adverse reactions (≥1%) include: upper respiratory tract
infections (16.3%, 14.7%, 11.7%), nausea (2.7%, 2.8%, 1.6%), herpes
simplex (0.8%, 1.8%, 0.7%), and herpes zoster (1.0%, 1.4%, 0.4%)
for OLUMIANT 2 mg, baricitinib 4 mg, and placebo, respectively.
USE IN SPECIFIC POPULATIONS
PREGNANCY AND LACTATION: No information is available to
support the use of OLUMIANT in pregnancy or lactation. Advise women
not to breastfeed during treatment with OLUMIANT.
HEPATIC AND RENAL IMPAIRMENT: OLUMIANT is not recommended
in patients with severe hepatic impairment or in patients with
moderate or severe renal impairment.
Please click to access full Prescribing
Information, including Boxed Warning about Serious
infections, Malignancies, and Thrombosis, and Medication
Guide.
BA HCP ISI 1JUNE2018
About OLUMIANT
OLUMIANT is a once-daily, oral JAK
inhibitor for the treatment of adults with moderately-to-severely
active rheumatoid arthritis who have had an inadequate response to
one or more TNF inhibitor therapies.1 There are four
known JAK enzymes: JAK1, JAK2, JAK3 and TYK2. JAK-dependent
cytokines have been implicated in the pathogenesis of a number of
inflammatory and autoimmune diseases.6 OLUMIANT has
greater inhibitory potency at JAK1, JAK2 and TYK2 relative to JAK3;
however, the relevance of inhibition of specific JAK enzymes to
therapeutic effectiveness is not currently known.1
OLUMIANT is approved in more than 40 countries.
About Rheumatoid Arthritis
Rheumatoid arthritis is a
systemic autoimmune disease characterized by inflammation and
progressive destruction of joints.2,3
Approximately three times as many women as men have the
disease.7 Current treatment of RA includes the use of
non-steroidal anti-inflammatory drugs, oral conventional synthetic
disease-modifying antirheumatic drugs (csDMARDs) — such as
methotrexate, the current standard of care, and injectable,
biological disease-modifying antirheumatic drugs (bDMARDs) that
target selected mediators implicated in the pathogenesis of
RA.7 Despite current treatment options, many patients do
not reach their therapeutic goals.9,10 There remains an
important need to provide additional treatment options to improve
overall patient care.
About Eli Lilly and Company
Lilly is a global
healthcare leader that unites caring with discovery to make life
better for people around the world. We were founded more than a
century ago by a man committed to creating high-quality medicines
that meet real needs, and today we remain true to that mission in
all our work. Across the globe, Lilly employees work to discover
and bring life-changing medicines to those who need them, improve
the understanding and management of disease, and give back to
communities through philanthropy and volunteerism. To learn more
about Lilly, please visit us at www.lilly.com and
newsroom.lilly.com/social-channels. P-LLY
About Incyte
Incyte Corporation is a Wilmington, Delaware-based biopharmaceutical
company focused on the discovery, development and commercialization
of proprietary therapeutics. For additional information on Incyte,
please visit the company's website at www.incyte.com.
Follow @Incyte on Twitter
at https://twitter.com/Incyte.
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 rheumatoid arthritis and reflects Lilly's and
Incyte's current beliefs. However, as with any pharmaceutical
product, there are substantial risks and uncertainties in the
process of development and commercialization. Among other things,
there can be no guarantee 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.
- Olumiant [package insert]. Indianapolis, IN: Eli Lilly and Company;
2018.
- Klareskog L, Catrina AI, Paget S. Lancet.
2009;373:659-672.
- Hand Clinics, Advances in the Medical Treatment of Rheumatoid
Arthritis,
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3135413/pdf/nihms305780.pdf.
Accessed April 23, 2018.
- Curtis JR and Singh JA. Clin
Ther. 2011;33(6):679-707.
- Reprinted with permission by First Databank, Inc. All rights
reserved. ©2016.
- Walker JG and Smith MD. J Rheumatol.
2005;32;1650-1653.
- Hunter TM, et al. Rheumatol Int. 2017;37:1551–1557.
- Arthritis Foundation, Rheumatoid Arthritis Treatment,
https://www.arthritis.org/about-arthritis/types/rheumatoid-arthritis/treatment.php.
Accessed April 23, 2018.
- Smolen JS, Aletaha D, McInnes IB. Lancet.
2016;388:2023-2038.
- Sustained Rheumatoid Arthritis Remission is Uncommon in
Clinical Practice, Arthritis Research & Therapy,
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3446437/. Accessed
April 23, 2018.
PP-BA-US-0403 06/2018 ©Lilly USA, LLC 2018. All rights reserved.
Refer to:
|
Danielle Neveles;
danielle.neveles@lilly.com; 317-796-4564 (Lilly media)
|
|
Kevin Hern;
hern_kevin_r@lilly.com; 317-277-1838 (Lilly investors)
|
|
Catalina Loveman;
cloveman@incyte.com; 302-498-6171 (Incyte media)
|
|
Michael Booth, DPhil;
mbooth@incyte.com; 302-498-5914 (Incyte investors)
|
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