INDIANAPOLIS, March 3, 2021 /PRNewswire/ -- Eli Lilly and
Company (NYSE: LLY) and Incyte (NASDAQ:INCY)
announced today top-line results from BRAVE-AA2, a Phase 3 study
evaluating the efficacy and safety of once-daily baricitinib 2-mg
and 4-mg in adults with severe alopecia areata (AA). Both doses of
baricitinib met the primary efficacy endpoint at Week 36,
demonstrating a statistically significant improvement in scalp hair
regrowth compared to those randomized to placebo. AA is an
autoimmune disease that causes patchy hair loss on the scalp, face
and sometimes on other areas of the body that can progress.
Baricitinib has received Breakthrough Therapy designation from the
U.S. Food and Drug Administration (FDA) for the treatment of AA.
This classification aims to expedite the development and review of
drugs that are intended to treat a serious condition when
preliminary clinical evidence indicates that the drug may
demonstrate substantial improvement over already available
therapies on a clinically significant endpoint(s). There are
currently no FDA-approved treatments for AA.
"These positive results are very promising and suggest that
baricitinib has the potential to address the urgent needs of people
living with alopecia areata," said Brett
King, M.D., Ph.D., associate professor of Dermatology at
Yale School of Medicine. "This level of
high-quality research is needed to advance our understanding and
the treatment of this frequently devastating disease."
This multicenter, randomized, double-blind, placebo-controlled
study included 546 adults with a Severity of Alopecia Tool (SALT)
score ≥ 50 (i.e., who had ≥50% scalp hair loss) and a current
episode of severe AA lasting at least six months but no more than
eight years. The study included a diverse patient population from
Argentina, Australia, Brazil, China, Israel, Japan, South
Korea, Taiwan and the
U.S.
Safety outcomes of baricitinib in BRAVE-AA2 were consistent with
its established safety profile in patients with rheumatoid
arthritis (RA) and atopic dermatitis (AD). No deaths, major adverse
cardiovascular events (MACE) or venous thromboembolic events (VTEs)
were reported in the study.
BRAVE-AA2 is the first Phase 3 study with positive results in
patients with AA. Data from an additional Phase 3 study of
baricitinib in AA will be available in the first half of this year.
Detailed results from the BRAVE program will be presented at an
upcoming medical conference and published in a peer-reviewed
journal later this year. AA is the second potential treatment
indication in dermatology for baricitinib after AD.
"For patients who suffer from alopecia areata, it is not a
cosmetic condition, it is a devastating autoimmune disease that can
have significant psychological effects. They lose much more than
just hair," said Lotus Mallbris, M.D., Ph.D., vice president of
immunology development at Lilly. "We are looking forward to sharing
the totality of data from the overall clinical development program
for baricitinib as a potential first-in-disease treatment for
alopecia areata."
"Significant unmet need exists in the treatment of alopecia
areata," said Abby Ellison, research
director at the National Alopecia Areata Foundation (NAAF). "We
appreciate Lilly's important work in this area and are excited that
these data could bring us closer to a potential new treatment
option for patients."
Baricitinib is an oral JAK inhibitor discovered by Incyte and
licensed to Lilly. It is approved and commercially available as
OLUMIANT in the U.S. and more than 70 countries as a treatment for
adults with moderate to severe active RA and in the European Union
and Japan for the treatment of
adult patients with moderate to severe AD who are candidates for
systemic therapy. Baricitinib is also being investigated in
systematic lupus erythematosus (SLE), juvenile idiopathic arthritis
(JIA) and COVID-19.
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. 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. and more than 70 countries as a treatment for adults with
moderate to severe rheumatoid arthritis (RA) and was recently
approved in the European Union and Japan for the treatment of adult patients with
moderate to severe atopic dermatitis who are candidates for
systemic therapy. The U.S. FDA-approved labeling for Olumiant
includes a Boxed Warning for Serious Infections, Malignancy, 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 baricitinib
and certain follow-on compounds for patients with inflammatory and
autoimmune diseases.
About Alopecia Areata
Alopecia Areata (AA) is an autoimmune disease that causes patchy
hair loss on the scalp, face and sometimes on other areas of the
body that can progress. AA often first appears during childhood and
can be different for everyone who has it. People of all ages,
males/females and all ethnic groups can develop AA.
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. 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.
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 atopic dermatitis and as a potential
treatment for patients with alopecia areata and 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 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, 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:
|
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)
|
|
Christine Chiou;
cchiou@incyte.com; +1-302-274-4773 (Incyte investors)
|
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SOURCE Eli Lilly and Company; Incyte