INDIANAPOLIS, Sept. 18, 2020 /PRNewswire/ -- Eli Lilly and
Company (NYSE:LLY) and Incyte (NASDAQ:INCY) announced today that
the European Medicines Agency's (EMA) Committee for Medicinal
Products for Human Use (CHMP) has issued a positive opinion for
baricitinib for the treatment of adult patients with moderate to
severe atopic dermatitis (AD) who are candidates for systemic
therapy.
This opinion marks the first step toward European regulatory
approval for baricitinib (marketed as OLUMIANT®) for
patients with AD. If approved, baricitinib would become the first
JAK inhibitor indicated to help treat patients with AD. The CHMP
opinion is now referred for action to the European Commission,
which grants approval in the European Union. A final decision is
expected from the European Commission in the next one-two
months.
"Due to the limited treatment options currently available for
adult patients with AD, we're excited to further explore
baricitinib's potential benefit for patients," said
Patrik Jonsson, Lilly senior vice
president and president of Lilly Bio-Medicines. "At Lilly, we
aspire to elevate treatment standards for patients with
dermatologic conditions. Today's CHMP opinion brings us closer to
providing a new medicine for adults living with AD in Europe."
The positive opinion was based on Lilly's Phase 3 BREEZE-AD
clinical development program for baricitinib evaluating the
medicine's potential to treat AD including BREEZE-AD1 and
BREEZE-AD2, monotherapy studies investigating the efficacy and
safety of baricitinib in moderate to severe AD patients;
BREEZE-AD4, a study evaluating the efficacy and safety of
baricitinib in combination with topical corticosteroids in patients
with moderate to severe AD who have failed or who are intolerant
to, or have contraindications to cyclosporine; and BREEZE-AD7, a
study evaluating the efficacy and safety of baricitinib in
combination with topical corticosteroids in patients with moderate
to severe AD.
"Patients living with AD face difficulties on a daily basis, and
this CHMP opinion marks an important milestone in providing adult
AD patients with a new potential treatment option," said Prof.
Thomas Bieber, M.D., Ph.D.,
M.D.R.A., Professor of Dermatology and Allergy, University Hospital
in Bonn, Germany.
OLUMIANT® is already approved in more than 70
countries as a treatment for adults with moderately to severely
active rheumatoid arthritis (RA).
Lilly has exclusive worldwide development and commercialization
rights for baricitinib and certain follow-on compounds for patients
with inflammatory and autoimmune diseases under a license and
collaboration agreement with Incyte.
Information on the previously approved EU OLUMIANT indication
(Rheumatoid Arthritis) can be found here.
Indication and Usage for OLUMIANT (baricitinib) tablets
(in the United States) for RA
patients
OLUMIANT® (baricitinib) 2-mg 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: Not recommended for use in
combination with other JAK inhibitors, biologic disease-modifying
antirheumatic drugs (DMARDs), or with potent immunosuppressants
such as azathioprine and cyclosporine.
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. 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.
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.
Closely 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
antimycobacterial 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 of ALT ≥5x upper limit of
normal (ULN) and increases of 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. 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.
HYPERSENSITIVITY: Reactions such as angioedema,
urticaria, and rash that may reflect drug sensitivity 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
Most common adverse reactions
include: upper respiratory tract infections (16.3%, 11.7%), nausea
(2.7%, 1.6%), herpes simplex (0.8%, 0.7%) and herpes zoster (1.0%,
0.4%) for Olumiant 2 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 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 09JUL2020
About OLUMIANT®
OLUMIANT is a once-daily, oral JAK inhibitor approved in the
U.S. 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, and approved outside of the
U.S. for patients with moderately- to severely active rheumatoid
arthritis who have had an inadequate response to one or more
DMARDs.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.2 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 70 countries. OLUMIANT is developed by Lilly under license
from Incyte Corporation.
About Atopic Dermatitis
Atopic dermatitis (AD), or
atopic eczema, is a chronic, relapsing skin disease characterized
by intense itching, dry skin and inflammation that can be present
on any part of the body.3 AD is a heterogeneous disease
both biologically and clinically, but may be characterized by
chronic symptoms of itch, redness and skin damage that are often
punctuated with episodic, sometimes unpredictable, flares or
exacerbations.4,5 AD affects approximately one-three
percent of adults worldwide.6
Moderate to severe AD is characterized by intense itching,
resulting in visibly damaged skin.7 Like other chronic
inflammatory diseases, AD is immune-mediated and involves a complex
interplay of immune cells and inflammatory
cytokines.8
About Lilly in Dermatology
By following the science
through unchartered territory, we continue Lilly's legacy of
delivering innovative medicines that address unmet needs and have
significant impacts on people's lives around the world.
Skin-related diseases are more than skin deep. We understand the
devastating impact this can have on people's lives. At Lilly, we
are relentlessly pursuing a robust dermatology pipeline to provide
innovative, patient-centered solutions so patients with
skin-related diseases can aspire to live life without
limitations.
About Eli Lilly and Company
Lilly is a global
health care leader that unites caring with discovery to create
medicines that 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 lilly.com and lilly.com/newsroom.
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.
P-LLY
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
atopic dermatitis 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 that it will 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.
1 Olumiant Prescribing Information, 2020.
2 Walker JG and Smith MD. J Rheumatol.
2005;32;1650-1653.
3 Zuberbier T, Orlow SJ, Paller AS, et al. Patient
perspectives on the management of atopic dermatitis. The Journal of
Allergy and Clinical Immunology. 2006;118: 226-32.
4 Thijs JL, Strickland I, Bruijnzeel-Koomen C, et.
al. Moving toward endotypes in atopic dermatitis: identification of
patient clusters based on serum biomarker analysis. The Journal of
Allergy and Clinical Immunology. 2017.
5 Langan SM, Thomas KS,
Williams HC. What is meant by "flare" in atopic dermatitis? A
systematic review and proposal. Arch Dermatol.
2006;142:1190-1196.
6 Nutten S. Atopic dermatitis: global epidemiology and
risk factors. Annals of Nutrition and Metabolism. 2015;66(suppl 1):
8-16.
7 Yosipovitch G, Papoiu AD. What causes itch in atopic
dermatitis? Current Allergy and Asthma Reports. 2008;8:306-311.
8 Weidinger, S, Novak, N. Atopic dermatitis. The Lancet
Volume 387. 2016;10023:1109-1122.
Refer to:
Kristen Porter Basu;
basu_kristen_porter@lilly.com; 317-447-2199 (media)
Kevin Hern; hern_kevin_r@lilly.com;
317-277-1838 (investors)
Catalina Loveman;
cloveman@incyte.com; +1-302-498-6171 (Incyte media)
Michael Booth, DPhil;
mbooth@incyte.com; +1-302-498-5914 (Incyte investors)
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