INDIANAPOLIS, Dec.
13, 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 granted Fast Track
designation to baricitinib, which is being studied for the
treatment of systemic lupus erythematosus (SLE). The Fast Track
designation process aims to facilitate the development and expedite
the review of new medicines that treat serious conditions and
fill unmet medical needs, with the goal of delivering potentially
important therapies to patients sooner.
Earlier this year, positive results of a Phase 2 study of
baricitinib for the treatment of SLE, which informed the FDA's Fast
Track designation, were published by The Lancet and
presented at the European Congress of Rheumatology.1
"There has been only one new treatment for SLE approved in the
U.S. in the past 50 years, and Lilly is excited to be at the
forefront of potentially bringing a new treatment option to
patients with this chronic, multi-organ autoimmune disease that can
cause widespread tissue damage," said Lotus Mallbris, M.D., Ph.D.,
vice president of immunology development at Lilly. "As part of the
Fast Track designation, we will work closely with the FDA to
further explore baricitinib's potential as a treatment that can
provide meaningful improvements for people with SLE."
Lilly is currently studying two doses of baricitinib in Phase 3
SLE trials. Additionally, Lilly is investigating baricitinib as a
potential treatment for moderate to severe atopic dermatitis, a
serious form of eczema, with Phase 3 results projected to be shared
during the first half of 2019. Baricitinib is approved in over 50
countries globally as OLUMIANT® for the treatment of
adults with rheumatoid arthritis.
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: 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.
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 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 01JUN2018
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. 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. OLUMIANT has
shown in non-clinical studies 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. OLUMIANT is approved in more than 50
countries.
About Systemic Lupus Erythematosus
Systemic lupus
erythematosus (SLE) is a chronic, multi-organ autoimmune disease
that can cause widespread tissue and organ damage. SLE is
characterized by periods of flare and remission and is associated
with a variety of symptoms, including extreme fatigue, unexplained
fever, joint pain/swelling and butterfly rash. Approximately 90
percent of all cases occur in women at a time when life and family
demands are greatest.
About Lilly in Immunology
Lilly is bringing our
heritage of championing groundbreaking, novel science to immunology
and is driven to change what's possible for people living with
autoimmune diseases. There are still significant unmet needs, as
well as personal and societal costs, for people living with a
variety of autoimmune diseases and our goal is to minimize the
burden of disease. Lilly is investing in leading-edge clinical
approaches across its immunology portfolio in hopes of transforming
the autoimmune disease treatment experience. We've built a deep
pipeline and are focused on advancing cutting edge science to find
new treatments that offer meaningful improvements to support the
people and the communities we serve.
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 a potential treatment for patients with
systemic lupus erythematosus and 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 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 Wallace DJ, et al. Lancet.
2018;392(10143):222-231.
Kristen Basu;
basu_kristen_porter@lilly.com; +1-317-447-2199 (Lilly media)
Kevin Hern; hern_kevin_r@lilly.com;
+1-317-277-1838 (Lilly 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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SOURCE Eli Lilly & Company