INDIANAPOLIS, June 13, 2022 /PRNewswire/ -- Eli Lilly and
Company (NYSE: LLY) and Incyte (NASDAQ:INCY) announced today that
the U.S. Food and Drug Administration (FDA) has approved
OLUMIANT® (baricitinib), a once-daily pill, as a
first-in-disease systemic treatment for adults with severe alopecia
areata (AA), available as 4-mg, 2-mg and 1-mg tablets.1
The recommended dose is OLUMIANT 2-mg/day, with an increase to
4-mg/day if treatment response is inadequate. For patients with
nearly complete or complete scalp hair loss, with or without
substantial eyelash or eyebrow hair loss, consider treating with
4-mg/day. Once an adequate response is achieved on 4-mg/day, the
dosage is to be decreased to 2-mg/day.1 OLUMIANT is not
recommended for use in combination with other JAK inhibitors,
biologic immunomodulators, cyclosporine or other potent
immunosuppressants.1
"People with alopecia areata, dermatologists and other
healthcare providers have been looking forward to this day when
there is an FDA-approved systemic medicine for this
often-devastating disease. Alopecia areata causes unpredictable
hair loss that can be patchy or complete, and it affects people of
all ages and ethnicities," 2-4 said Brett King, M.D., Ph.D., F.A.A.D., associate
professor of dermatology at Yale School of
Medicine and lead investigator of the BRAVE-AA program. "I
am so happy that adults with severe alopecia areata can now take
OLUMIANT, a once-daily pill. The results of clinical trials are
remarkable, as one in five adults taking OLUMIANT 2-mg/day and one
in three taking OLUMIANT 4-mg/day achieved significant hair
regrowth resulting in 80% or more scalp coverage, and eyebrow and
eyelash improvements were also achieved for patients taking
OLUMIANT 4-mg/day with substantial eyebrow or eyelash hair
loss."1
The approval was based on Lilly's BRAVE-AA1 and BRAVE-AA2
trials, the largest Phase 3 AA clinical trial program completed to
date,5-7 evaluating the efficacy and safety of OLUMIANT
in 1,200 adult patients with severe AA (≥50% scalp hair loss as
defined by a Severity of Alopecia Tool (SALT) score
≥50).1 Across the studies at 36 weeks, 17-22% of
patients taking OLUMIANT 2-mg/day and 32-35% of patients taking
OLUMIANT 4-mg/day achieved 80% or more scalp hair coverage,
compared to 3-5% taking placebo.1 Additionally, 11-13%
of patients taking OLUMIANT 2-mg/day and 24-26% of patients taking
OLUMIANT 4-mg/day achieved 90% or more hair coverage, compared to
1-4% of patients taking placebo; results for OLUMIANT 2-mg/day were
not statistically significant under the multiplicity control plan
for BRAVE-AA2.1
Among patients with substantial eyebrow and eyelash hair loss at
baseline, improvements in eyebrow and eyelash coverage were seen
for patients taking OLUMIANT 4-mg daily at 36
weeks.1
The BRAVE-AA clinical program evaluated the safety profile of
OLUMIANT.1 Few patients discontinued treatment due to
adverse events (average of 2.2% across both studies) in the 36-week
placebo-controlled period and the majority of treatment-emergent
adverse events were mild or moderate in
severity.8 The most commonly reported adverse
reactions (≥1%) were upper respiratory tract infections, headache,
acne, high cholesterol levels, increases in blood markers related
to the muscle, urinary tract infections, elevated liver enzyme
levels, inflammation of hair follicles, fatigue, lower respiratory
tract infections, nausea, genital yeast infection, low red blood
cell counts, low white blood cell counts, abdominal pain, shingles
and weight increase.1 The U.S. FDA-approved
labeling for OLUMIANT includes a boxed warning for risk of serious
infections, mortality, malignancy, major adverse cardiovascular
events (MACE) and thrombosis.1 See below for full
Important Safety Information.
"Today marks a milestone with the first-ever FDA-approved
systemic treatment for alopecia areata patients, who face
significant challenges every day including limited public knowledge
about the disease, a lack of treatment options and social
stigma,"9 said Nicole
Friedland, president and chief executive officer, National
Alopecia Areata Foundation (NAAF). "The approval of OLUMIANT can
spark hope for many patients and encourage new treatment
conversations with their doctors. NAAF wants more choices for our
patient community and with the approval of OLUMIANT, there are now
new treatment expectations being established in alopecia areata
care."
Lilly is committed to ensuring patients have access to
much-needed medicines and is working with insurers to do so.
Through the OLUMIANT TogetherTM support program,
Lilly offers a savings card for eligible commercially insured
patients* to help with out-of-pocket costs where they pay as little
as $5/month if covered by their
insurance provider or $25/month if
not covered by their plan. The savings card is available at
specialty pharmacies, and in the coming days will be available for
download on OLUMIANT.com.
"There is a significant unmet medical need for people with
alopecia areata given there has never been an FDA-approved systemic
medicine. In fact, a study published in 2017 of 1,083 people with
AA showed that nearly 80 percent were unsatisfied with their
treatment options,"10 said Patrik Jonsson, Lilly senior vice president,
president of Lilly Immunology and Lilly USA, and chief customer officer. "Our mission
is to make life better for people living with debilitating
immune-mediated diseases. OLUMIANT's approval is a historic moment,
and we're delighted about what it can mean for adults with severe
alopecia areata."
Learn more about OLUMIANT; view the 2-mg and 4-mg product photos
and brand logo.
OLUMIANT is a once-daily, oral JAK inhibitor discovered by
Incyte and licensed to Lilly and is available through specialty
pharmacies nationwide. Lilly also expects regulatory decisions
for OLUMIANT in AA in the European Union and Japan in
2022.
About BRAVE-AA1 and BRAVE-AA2
In these double-blind,
placebo-controlled Phase 3 trials, 1,200 patients with severe AA
were randomized to receive once-daily OLUMIANT 2-mg, OLUMIANT 4-mg
or placebo.
- The primary endpoint was the proportion of patients achieving
SALT ≤20 (i.e., 80% or more scalp hair coverage) at Week
36.1 Across both studies, 17-22% of patients taking
OLUMIANT 2-mg/day (BRAVE-AA1=22% [n=40/184]; BRAVE-AA2=17%
[n=27/156]) and 32-35% of patients treated with OLUMIANT 4-mg/day
(BRAVE-AA1=35% [n=99/281]; BRAVE-AA2=32% [n=76/234]) achieved 80%
or more scalp hair coverage, compared to 5% (n=10/189) and 3%
(n=4/156) of patients taking placebo in BRAVE-AA1 and BRAVE-AA2,
respectively (p≤0.001 for all comparisons to placebo).
- Additionally, 11-13% of patients taking OLUMIANT 2-mg/day
(BRAVE-AA1=13% [n=23/184]; BRAVE-AA2=11% [n=17/156]) and 24-26% of
patients taking OLUMIANT 4-mg/day (BRAVE-AA1=26% [n=73/281];
BRAVE-AA2=24% [n=55/234]) achieved 90% or more hair coverage,
compared to 4% (n=7/189) and 1% (n=1/156) of patients taking
placebo in BRAVE-AA1 and BRAVE-AA2, respectively (p<=0.001 for
OLUMIANT 4-mg/day comparisons to placebo; p<=0.01 for OLUMIANT
2-mg/day comparison to placebo in BRAVE-AA1).1,8 SALT 10
(90% hair coverage) results for OLUMIANT 2-mg/day were not
statistically significant under the multiplicity control plan for
BRAVE-AA2.8
Indications and Usage for OLUMIANT (baricitinib) tablets (in
the United States)
OLUMIANT is indicated for the treatment of adult patients with
severe alopecia areata.
Limitations of Use: Not recommended for use in
combination with other JAK inhibitors, biologic immunomodulators,
cyclosporine or other potent immunosuppressants.
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)
blockers.
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.
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.
GASTROINTESTINAL PERFORATIONS
Gastrointestinal perforations have been reported in Olumiant
clinical studies. 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 or alopecia areata (AA), 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 or AA, 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 or AA, 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 or
AA. 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 or AA prior to initiating Olumiant therapy in
agreement with current immunization guidelines.
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.
In AA trials, the most common adverse reactions (≥1%) reported
with Olumiant were: upper respiratory tract infections, headache,
acne, hyperlipidemia, creatine phosphokinase increase, urinary
tract infections, liver enzyme elevations, folliculitis, fatigue,
lower respiratory tract infections, nausea, genital Candida
infections, anemia, neutropenia, abdominal pain, herpes zoster, and
weight increase.
PREGNANCY AND LACTATION
Based on animal studies, Olumiant may cause fetal harm when
administered during pregnancy. Advise pregnant women and women of
reproductive potential of the potential risk to a fetus. Consider
pregnancy planning and prevention for women of reproductive
potential. Advise women not to breastfeed during treatment with
Olumiant and for 4 days after the last dose.
HEPATIC AND RENAL IMPAIRMENT
Olumiant is not recommended in patients with RA or AA 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 13JUN2022
*Savings Card Terms and Conditions
Offer good until
12/31/2024 or up to 36 months from patient qualification into
the program, whichever comes first. Patients must first use their
card by 12/31/2022. Patients must have coverage for Olumiant
through their commercial drug insurance to pay as little as
$5 for a 30-day supply of Olumiant.
Offer subject to a monthly cap and a separate annual
cap. Patients must have commercial drug insurance and
prescription consistent with FDA-approved product labeling to pay
as little as $25 for a 30-day supply
of Olumiant. Participation in the $25
program requires submission of a prior authorization (PA). If
coverage is denied, an appeal must be submitted prior to the
5th month fill. A new PA and appeal or medical exception
(ME) must be submitted every 12 months or as required by Lilly to
verify coverage status and potential eligibility for the
$5 program. Monthly and annual caps
are set at Lilly's absolute discretion and may be changed by Lilly
with or without notice. Patient is responsible for any applicable
taxes, fees, or amounts exceeding monthly or annual caps. This
offer is invalid for patients without commercial drug insurance or
whose prescription claims for Olumiant are eligible to be
reimbursed, in whole or in part, by any governmental program,
including, without limitation, Medicaid, Medicare, Medicare Part D,
Medigap, DoD, VA, TRICARE®/CHAMPUS, or any state patient
or pharmaceutical assistance program. Offer void where
prohibited by law and subject to change or discontinue without
notice. Card activation is required. Subject to additional terms
and conditions, which can be found at
olumiant.com/olumiant-together.
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. 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. 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® and OLUMIANT TogetherTM are
trademarks owned or licensed by Eli Lilly and Company, its
subsidiaries, or affiliates.
Other trademarks listed are the property of their respective
owners.
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 alopecia
areata 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.
- Olumiant. Prescribing Information. Lilly USA, LLC.
- Pratt CH, King LE Jr, Messenger AG, et al. Alopecia areata.
Nat Rev Dis Primers. 2017;3:17011.
- Wang EHC, Sallee BN, Tejeda CI, et al. Janus kinase inhibitors
for treatment of alopecia areata. J Invest Dermatol.
2018;138:1911-1916.
- Strazzulla LC, Wang EHC, Avila L, et al. Alopecia areata:
disease characteristics, clinical evaluation, and new perspectives
on pathogenesis. J Am Acad Dermatol. 2018;78:1-12.
- Pfizer Inc. (2018, November - 2022, February). PF-06651600 for
the Treatment of Alopecia Areata (ALLEGRO-2b/3). Identifier
NCT03732807.
https://clinicaltrials.gov/ct2/show/results/NCT03732807
- Concert Pharmaceuticals (2020, August). A Phase 3 Study to
Evaluate the Efficacy and Safety of CTP-543 in Adult Patients With
Moderate to Severe Alopecia Areata (THRIVE-AA1) (THRIVE-AA1).
Identifier NCT04797650.
https://clinicaltrials.gov/ct2/show/NCT04797650.
- Concert Pharmaceuticals (2021, March). A Phase 3 Study to
Evaluate the Efficacy and Safety of CTP-543 in Adult Patients With
Moderate to Severe Alopecia Areata (THRIVE-AA2)
(THRIVE-AA2). Identifier NCT04518995.
https://clinicaltrials.gov/ct2/show/NCT04518995.
- Data on file. Lilly USA, LLC.
DOF-BA-US-0075.
- U.S. Food & Drug Administration. The voice of the patient:
a series of reports from the U.S. Food and Drug Administration's
(FDA) patient-focused drug development initiative: Alopecia Areata.
Meeting date: September 11, 2017;
report date: 2018. https://www.fda.gov/media/112100/download.
Accessed 18 March 2022.
- Hussain ST, Mostaghimi A, Barr PJ, et al. Utilization of mental
health resources and complementary and alternative therapies for
alopecia areata: a U.S. survey. Int J Trichology.
2017;9(4):160-164.
PP-BA-US-1807 06/2022 © Lilly USA, LLC 2022. All rights reserved.
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