INDIANAPOLIS, June 1, 2020 /PRNewswire/ -- Eli Lilly and
Company (NYSE: LLY) announced today the U.S. Food and Drug
Administration (FDA) has approved a supplemental Biologics License
Application (sBLA) for Taltz® (ixekizumab) injection 80
mg/mL for the treatment of active non-radiographic axial
spondyloarthritis (nr-axSpA) in patients with objective signs of
inflammation. Another first-in-class milestone for the treatment,
today's approval makes Taltz the first IL-17A antagonist to be
approved by the FDA for nr-axSpA.
Axial spondyloarthritis (axSpA), which includes both AS and
nr-axSpA, is a disease predominantly affecting the sacroiliac
joints and the spine, resulting in chronic inflammatory back pain
and fatigue.1,2,3 It is estimated that 2.3 million
people in the U.S. have axSpA, and approximately half of those
individuals live with nr-axSpA.2,4 For
patients with AS, the disease is characterized by the presence of
structural damage of the sacroiliac joints that appears on an
X-ray, while patients with nr-axSpA do not have clearly detectable
structural damage radiographically.5 These two patient
subsets share a similar burden of disease and similar clinical
features, but approved biologic treatment options for patients with
nr-axSpA are much more limited and patients are often
underdiagnosed.5,6
"We recognize that many patients living with this condition
suffer from chronic inflammatory back pain and other symptoms of
inflammation for years before being diagnosed, and we're excited
about the possibility of these patients finding relief with Taltz,"
said Patrik Jonsson, senior vice
president and president of Lilly Bio-Medicines. "This approval
reflects Lilly's continued growth and commitment to supporting
rheumatologists and people with autoimmune conditions, including
nr-axSpA."
This approval is based on the results from the Phase 3 COAST-X
trial, which evaluated improvement in signs and symptoms of
nr-axSpA as measured by the proportion of patients who achieved
Assessment of Spondyloarthritis International Society 40 (ASAS40)
response criteria compared to placebo. ASAS40 measures disease
signs and symptoms such as pain, inflammation and function.
The safety profile of Taltz in patients with nr-axSpA was
consistent with previous experience with Taltz in other approved
indications. Taltz should not be used in patients with a
previous serious hypersensitivity reaction, such as anaphylaxis, to
ixekizumab or to any of the excipients. Taltz may increase the risk
of infection. Other warnings and precautions for Taltz include
pre-treatment evaluation for tuberculosis, hypersensitivity,
inflammatory bowel disease, and immunizations. See Important Safety
Information below.
"There are limited treatment options that can address both AS
and nr-axSpA symptoms, and people living with these conditions are
often underdiagnosed and undertreated," said Cassie Shafer, chief executive officer of the
Spondylitis Association of America. "This approval represents an
important milestone in providing relief to patients where there has
been a significant unmet need."
This approval reaffirms the long track record that Taltz has in
providing efficacy for patients in multiple indications. This is
the fifth approval for Taltz, which was first approved by the FDA
in March 2016 for the treatment of
moderate to severe plaque psoriasis (PsO) in adult patients who are
candidates for systemic therapy or phototherapy. The FDA also
approved Taltz for the treatment of adults with active psoriatic
arthritis (PsA) in December 2017, for
the treatment of adults with active AS in August 2019 and
for moderate to severe plaque PsO in pediatric patients 6 years of
age and older who are candidates for systemic therapy or
phototherapy in March 2020.
In COAST-X, the safety and efficacy of Taltz was demonstrated in
a Phase 3, multicenter, randomized, double-blind,
placebo-controlled 52-week study of adult patients with active
nr-axSpA with objective signs of inflammation. The primary endpoint
of the study was the proportion of patients achieving ASAS40 at
Week 52. The proportion of Taltz patients (n=96) achieving the
primary endpoint was superior to placebo (n=105), with 30 percent
of patients treated with Taltz 80 mg every four weeks achieving
ASAS40 response compared to 13 percent of patients treated with
placebo at Week 52 (P=0.0045). A major secondary endpoint was
ASAS40 response at Week 16 with 35 percent of Taltz patients
compared to 19 percent of placebo patients achieving that endpoint
(P<0.01).
"In the COAST-X study, Taltz provided relief to nr-axSpA
patients living with debilitating symptoms such as chronic back
pain and fatigue," said Atul
Deodhar, M.D., professor of medicine, Oregon Health &
Science University and clinical investigator for the COAST pivotal
trial program. "The study results indicate that Taltz is safe and
effective in patients suffering from this condition. Today's FDA
approval provides patients with a much-needed treatment option
targeting IL-17A to improve the signs and symptoms of
nr-axSpA."
Other major secondary endpoints of the study included Ankylosing
Spondylitis Disease Activity Score (ASDAS), Bath Ankylosing
Spondylitis Disease Activity (BASDAI), the proportion of patients
achieving low disease activity (ASDAS <2.1) and the 36-Item
Short Form Health Survey (SF-36) Physical Component Summary (PCS)
Score.
An estimated 137,000 patients have been treated with Taltz
worldwide since launch, with approximately 80,000 of those in the
U.S., giving rheumatologists confidence in making informed
prescribing decisions for patients with PsO, PsA, AS and
nr-axSpA.7
Lilly will work with insurers, health systems and providers to
ensure patients are able to access this treatment. We recognize
that COVID-19 may be impacting the ability for people to afford
their medications, and the Taltz TogetherTM program
helps ensure patients pay the lowest amount possible and can have
Taltz delivered straight to their homes. Patients, physicians,
pharmacists or other healthcare professionals with questions about
Taltz should contact The Lilly Answers Center at 1-800-LillyRx
(1-800-545-5979) or visit www.lilly.com. If you'd like
to learn more about insurance support, call at 1-844-TALTZ-NOW
(1-844-825-8966) or visit
www.taltz.com/patient-support.
INDICATIONS AND USAGE FOR TALTZ
Taltz is approved for
the treatment of adult patients with active non-radiographic axial
spondyloarthritis with objective signs of inflammation, active
psoriatic arthritis, or active ankylosing spondylitis, and for the
treatment of patients 6 years of age and older with
moderate-to-severe plaque psoriasis who are candidates for systemic
therapy or phototherapy.
IMPORTANT SAFETY INFORMATION FOR TALTZ
CONTRAINDICATIONS
Taltz is contraindicated in patients
with a previous serious hypersensitivity reaction, such as
anaphylaxis, to ixekizumab or to any of the excipients.
WARNINGS AND PRECAUTIONS
Infections
Taltz
may increase the risk of infection. In clinical trials of adult
patients with plaque psoriasis, the Taltz group had a higher rate
of infections than the placebo group (27% vs 23%). A similar
increase in risk of infection was seen in placebo-controlled trials
of adult patients with psoriatic arthritis, ankylosing spondylitis,
non-radiographic axial spondyloarthritis, and pediatric patients
with plaque psoriasis. Serious infections have occurred. Instruct
patients to seek medical advice if signs or symptoms of clinically
important chronic or acute infection occur. If a serious infection
develops, discontinue Taltz until the infection resolves.
Pre-Treatment Evaluation for Tuberculosis
Evaluate patients for tuberculosis (TB) infection prior to
initiating treatment with Taltz. Do not administer to patients with
active TB infection. Initiate treatment of latent TB prior to
administering Taltz. Closely monitor patients receiving Taltz for
signs and symptoms of active TB during and after treatment.
Hypersensitivity
Serious hypersensitivity reactions,
including angioedema and urticaria (each ≤0.1%), occurred in the
Taltz group in clinical trials. Anaphylaxis, including cases
leading to hospitalization, has been reported in post-marketing use
with Taltz. If a serious hypersensitivity reaction occurs,
discontinue Taltz immediately and initiate appropriate therapy.
Inflammatory Bowel Disease
Patients treated with Taltz may be at an increased risk of
inflammatory bowel disease. In clinical trials, Crohn's disease and
ulcerative colitis, including exacerbations, occurred at a greater
frequency in the Taltz group than the placebo group. During Taltz
treatment, monitor patients for onset or exacerbations of
inflammatory bowel disease and if IBD occurs, discontinue Taltz and
initiate appropriate medical management.
Immunizations
Prior to initiating therapy with Taltz, consider completion of all
age-appropriate immunizations according to current immunization
guidelines. Avoid use of live vaccines in patients treated with
Taltz.
ADVERSE REACTIONS
Most common adverse reactions (≥1%) associated with Taltz treatment
are injection site reactions, upper respiratory tract infections,
nausea, and tinea infections. Overall, the safety profiles observed
in adult patients with psoriatic arthritis, ankylosing spondylitis,
non-radiographic axial spondyloarthritis, and pediatric patients
with plaque psoriasis were consistent with the safety profile in
adult patients with plaque psoriasis, with the exception of
influenza and conjunctivitis in psoriatic arthritis and
conjunctivitis, influenza, and urticaria in pediatric
psoriasis.
Please see full Prescribing Information and Medication Guide
for Taltz. See Instructions for Use included with the
device.
IX HCP ISI 07MAY2020
About Taltz®
Taltz is a monoclonal
antibody that selectively binds with interleukin 17A (IL-17A)
cytokine and inhibits its interaction with the IL-17
receptor.8 IL-17A is a naturally occurring cytokine
that is involved in normal inflammatory and immune
responses. Taltz inhibits the release of pro-inflammatory
cytokines and chemokines.7
About the COAST-X Study
COAST-X is a multicenter,
randomized, double-blind, placebo-controlled 52-week study
evaluating the efficacy and safety of Taltz for the treatment of
active non-radiographic axial spondyloarthritis (nr-axSpA) in
patients with objective signs of inflammation. Patients were
required to have an established diagnosis of nr-axSpA and active
disease defined by a Bath Ankylosing Spondylitis Disease Activity
Index (BASDAI) Numeric Rating Scale (NRS) score ≥4 and total back
pain ≥4 at screening and baseline, and were required to have
objective signs of inflammation by presence of sacroiliitis on MRI
or presence of elevated CRP.
About the Taltz Program in axSpA
The COAST-X study is
part of a clinical development program that aims to evaluate the
efficacy and safety of Taltz across various population subsets of
patients with axSpA. The COAST program includes three registration
studies each of one year duration: COAST-V in patients with
ankylosing spondylitis (AS)/radiographic axSpA who are
biologic-naive; COAST-W in patients with AS/radiographic axSpA who
previously had an inadequate response or were intolerant to tumor
necrosis factor (TNF) inhibitors; and COAST-X in biologic-naive
nr-axSpA patients with objective signs of inflammation. Patients
may enroll into a long-term extension study (COAST-Y) after
completion of any of these registration studies to receive Taltz
treatment for up to an additional two years.
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 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/news.
P-LLY
This press release contains forward-looking statements (as that
term is defined in the Private Securities Litigation Reform Act of
1995) about Taltz (ixekizumab) as a treatment for patients with
non-radiographic axial spondyloarthritis and reflects Lilly's
current belief. 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 Taltz will receive additional regulatory
approvals or be commercially successful. For further discussion of
these and other risks and uncertainties, see Lilly's most recent
Form 10-K and Form 10-Q filings with the United States Securities
and Exchange Commission. Except as required by law, Lilly
undertakes no duty to update forward-looking statements to reflect
events after the date of this release.
PP-IX-US-3694 05/2020 © Lilly USA, LLC 2020. All rights reserved.
1 Reveille JD, et al. Prevalence of axial
spondylarthritis in the United
States: Estimates from a cross-sectional survey.
Arthritis Care Res. 2012;64(6):905-910.
2 Strand V, et al. Prevalence of axial
spondyloarthritis in United States
rheumatology practices: Assessment of SpondyloArthritis
International Society criteria versus rheumatology expert clinical
diagnosis. Arthritis Care Res. 2013;65(8):1299-306.
3 Kiltz U, et al. Do patients with non-radiographic
axial spondylarthritis differ from patients with ankylosing
spondylitis? Arthritis Care Res. 2012;64(9):1415-22.
4 U.S. Census Bureau, Population Estimates Program (PEP)
https://www.census.gov/quickfacts/fact/table/US# accessed on
April 30, 2020.
5 Deodhar A, et al. The concept of axial
spondyloarthritis: joint statement of the spondyloarthritis
research and treatment network and the Assessment of
SpondyloArthritis International Society in response to the US Food
and Drug Administration's comments and concerns. Arth Rheum.
2014;66(10):2649-2656.
6 De Miguel Mendieta E, et al. Ann Rhuem Dis.
2018;77:1156. Abstract AB0857.
7 Data on File. Lilly USA, LLC. DOF-IX-US-0240.
8 Taltz Prescribing Information, 2020.
Refer to:
|
Carla Cox;
cox_carla@lilly.com; 317-750-3923 (media)
|
|
Kevin Hern;
hern_kevin_r@lilly.com; 317-277-1838 (investors)
|
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