INDIANAPOLIS, May 20, 2022
/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 OLUMIANT® (baricitinib)
for the treatment of adults with severe alopecia areata (AA).
This opinion marks the first step toward European regulatory
approval of OLUMIANT for patients with severe AA, and it is now
referred to the European Commission for final action. If approved,
OLUMIANT would be the first centrally-authorized oral treatment and
first JAK inhibitor for patients with severe AA in the European
Union. The European Commission's decision is expected in the next
one to two months.
"Alopecia areata is an often-misunderstood autoimmune disease
that can lead to unpredictable hair loss, ranging from bald patches
to complete loss of all hair. The disease carries significant
psychosocial burden and can impact patients of any race, ethnicity,
or age, with many experiencing alopecia in their early to mid-20s,"
said Bianca Maria Piraccini, M.D.,
Ph.D., professor and head of the Dermatology Unit at the University
of Bologna. "As there has never been a centrally-authorized therapy
for alopecia areata, I'm delighted about Lilly's potential to
provide this oral medicine with statistically significant and
clinically meaningful Phase 3 clinical trial results for adults
with severe alopecia areata across Europe."
The positive opinion was based on Lilly's Phase 3 BRAVE-AA1 and
BRAVE-AA2 trials evaluating the efficacy and safety of OLUMIANT in
1,200 patients with severe AA, the largest Phase 3 clinical trial
program with completed primary endpoints. Severe AA was defined as
having a Severity of Alopecia Tool (SALT) score ≥50 (≥50% scalp
hair loss). The primary endpoint was the proportion of patients
achieving SALT ≤20 (i.e., 80% or more scalp hair coverage) at Week
36. Across both studies, 1 out of 3 patients treated with OLUMIANT
4-mg achieved 80% or more scalp hair coverage (BRAVE-AA1=35.2%
[n=99]; BRAVE-AA2=32.5% [n=76]), compared to 1 out of 20 patients
(5.3%, n=10) and 1 out of 50 patients (2.6%, n=4) taking placebo in
BRAVE-AA1 and BRAVE-AA2, respectively (p≤0.001 for all comparisons
to placebo).
Achievement of full regrowth or regrowth with minimal gaps in
eyebrow and eyelash hair was also seen at 36 weeks with OLUMIANT
4-mg for 1 in 3 patients who at baseline had significant gaps or no
notable eyebrows or eyelashes, as compared to patients taking
placebo (BRAVE-AA1: 4-mg dose: eyebrow=31.4% [n=59]; eyelash=33.5%
[n=56]; placebo: eyebrow=3.2% [n=4]; eyelash=3.1% [n=3]; BRAVE-AA2:
4-mg dose: eyebrow=34.8% [n=56]; eyelash=34.3% [n=48]; placebo:
eyebrow=4.5% [n=5]; eyelash=5.6% [n=5]; p≤0.001 for all comparisons
to placebo). Eyebrow and eyelash hair loss was evaluated using the
Clinician-Reported Outcome (ClinRO) Measure for Eyebrow Hair Loss™
and ClinRO Measure for Eyelash Hair Loss™ – novel,
clinically-validated tools developed by Lilly.
The Phase 3 BRAVE-AA clinical program also evaluated the safety
profile of OLUMIANT, and no new safety signals were observed. Few
patients discontinued treatment due to adverse events (2.6% or less
across both studies), and the majority of treatment-emergent
adverse events were mild or moderate in severity.
"We're proud of today's CHMP opinion as it reflects our
commitment to immunological diseases with high unmet need," said
Patrik Jonsson, Lilly senior vice
president, president of Lilly Immunology and Lilly USA, and chief customer officer. "This is a
significant step for OLUMIANT on the path to becoming the first and
only centrally-authorized medicine in Europe for adults with severe alopecia areata.
We eagerly anticipate additional regulatory decisions around the
world this year."
In February 2022, the U.S. Food and Drug
Administration (FDA) granted priority review for OLUMIANT in
adults with severe AA. Lilly expects additional
regulatory decisions in the U.S. and Japan in
2022.
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 and is approved in more than 50 countries,
including the European Union and Japan, for the treatment of adult patients
with moderate to severe atopic dermatitis who are candidates for
systemic therapy. FDA approval was granted for OLUMIANT for the
treatment of certain hospitalized adult patients with COVD-19 in
May 2022. Marketing authorization for
OLUMIANT in COVID-19 has been granted in six other countries
including Japan and Switzerland. Baricitinib is authorized for
emergency use in eight countries. Over 400,000 patients have been
treated with OLUMIANT for approved indications, in addition to
nearly one million patients with COVID-19 worldwide. 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. OLUMIANT is being investigated in alopecia areata
(AA), juvenile idiopathic arthritis (JIA) and in pediatric patients
with atopic dermatitis (AD).
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.
Indications and Usage for OLUMIANT (baricitinib) tablets (in
the United States)
OLUMIANT 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. Limitations 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.
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 ALC <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 RA 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 RA trials, the most common adverse reactions (≥1%) reported
with Olumiant were: upper respiratory tract infections, nausea,
herpes simplex, and herpes zoster.
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 is not recommended in patients with RA and severe
hepatic impairment or severe renal impairment (estimated glomerular
filtration rate [eGFR] <30 mL/min/1.73m2).
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 ALL 17MAY2022
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.
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.
P-LLY
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
rheumatoid arthritis and as a possible treatment for other
conditions 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.
Refer to:
|
Marlo
Scott; scott_marlo@lilly.com; +1-317-407-8879
(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)
|
|
Christine Chiou;
cchiou@incyte.com; +1-302-274-4773 (Incyte investors)
|
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SOURCE Eli Lilly and Company; Incyte