INDIANAPOLIS, Dec. 1, 2017 /PRNewswire/ -- Eli Lilly
and Company (NYSE: LLY) announced today that the U.S. Food and Drug
Administration (FDA) has approved Taltz® (ixekizumab)
injection 80 mg/mL for the treatment of adults with active
psoriatic arthritis (PsA).1 Taltz was first approved by
the FDA in March 2016 for the
treatment of adult patients with moderate-to-severe plaque
psoriasis who are candidates for systemic therapy or
phototherapy.1
"PsA is a chronic, progressive and painful form of inflammatory
arthritis that impacts approximately 1.6 million Americans living
with the disease," said Christi
Shaw, president, Lilly Bio-Medicines. "We are proud to offer
a new treatment option that can provide improvements in joint
symptoms for these patients, further demonstrating Lilly's overall
commitment to immunology."
Taltz may be administered alone or in combination with a
conventional disease-modifying antirheumatic drug, such as
methotrexate.1 Taltz should not be used in patients with
a previous serious hypersensitivity reaction, such as anaphylaxis,
to ixekizumab or to any of the excipients.1 Taltz may
increase the risk of infection.1 Other warnings and
precautions for Taltz include pre-treatment evaluation for
tuberculosis, hypersensitivity reactions, inflammatory bowel
disease and immunizations.1 See Important Safety
Information below.1
The efficacy and safety of Taltz was determined from findings
from two randomized, double-blind, placebo-controlled Phase 3
studies – SPIRIT-P1 and SPIRIT-P2 – which included more than 670
adult patients with active PsA.1 SPIRIT-P1 evaluated the
safety and efficacy of Taltz compared to placebo in patients with
active PsA who had never been treated with a biologic
disease-modifying antirheumatic drug.1 SPIRIT-P2
evaluated the safety and efficacy of Taltz compared to placebo in
tumor necrosis factor inhibitor (TNFi)-experienced patients with
active PsA who failed one or two TNF inhibitors.1 Across
both studies, patients were required to have a diagnosis of active
PsA for at least six months and at least three tender and three
swollen joints.1 Non-responder imputation (NRI) methods
were used. Inadequate responders (defined by blinded tender and
swollen joint count criteria) at Week 16 received rescue therapy
and were analyzed as non-responders.1
In studies of biologic-naïve and TNFi-experienced patients, the
primary efficacy endpoint was the proportion of patients at 24
weeks achieving ACR20 response, which represents a 20 percent
reduction in a composite measure of disease activity as defined by
the American College of Rheumatology (ACR).1 Results
from both studies demonstrated that patients treated with Taltz
achieved significant improvement in joint symptoms, as measured by
ACR20, compared with placebo.1 At 24 weeks, patients
achieved ACR20 at the following response rates:
- SPIRIT-P1: 58 percent of patients treated with Taltz vs. 30
percent for placebo1
- SPIRIT-P2: 53 percent of patients treated with Taltz vs. 20
percent for placebo1
"For patients with PsA, treatment goals often include
improvement in joint symptoms," said Philip
Mease, M.D., Swedish Medical Center and University of Washington. "Based on the study
results, Taltz can provide significant improvement in joint
symptoms for patients who had never been treated with a biologic
disease-modifying antirheumatic drug as well as patients who had
inadequate response to one or two TNF inhibitors or were intolerant
of TNF inhibitors."
Lilly will work with insurers, health systems and providers to
ensure patients are able to access this treatment. 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.
Indications and Usage
Taltz is approved for the
treatment of adults with active psoriatic arthritis.1
Taltz is also approved to treat adults with moderate to severe
plaque psoriasis who are candidates for systemic therapy or
phototherapy.1
IMPORTANT SAFETY INFORMATION
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 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 patients with psoriatic arthritis.
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
During Taltz treatment,
monitor patients for onset or exacerbations of inflammatory bowel
disease. Crohn's disease and ulcerative colitis, including
exacerbations, occurred at a greater frequency in the Taltz group
(Crohn's disease 0.1%, ulcerative colitis 0.2%) than in the placebo
group (0%) during clinical trials in patients with plaque
psoriasis.
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 profile observed in patients with psoriatic
arthritis was consistent with the safety profile in patients with
plaque psoriasis, with the exception of influenza and
conjunctivitis.
Please click to access the Prescribing Information
and Medication Guide. Please click to access
Instructions for Use included with the device.
IX HCP ISI 01DEC2017
About Psoriatic Arthritis
Psoriatic arthritis (PsA)
is a chronic, progressive form of inflammatory arthritis that can
cause swelling, stiffness and pain in and around the joints and
impaired physical function.2 It occurs when an
overactive immune system sends out faulty signals that cause
inflammation, leading to swollen and painful joints and
tendons.2 Psoriatic arthritis can affect peripheral
joints in the arms and legs (elbows, wrists, hands and
feet).2 If left untreated, PsA can cause permanent joint
damage.2 Up to 30 percent of people with psoriasis also
develop PsA.2
About Taltz®
Taltz®
(ixekizumab) is a monoclonal antibody that selectively binds with
interleukin 17A (IL-17A) cytokine and inhibits its interaction with
the IL-17 receptor.1 IL-17A is a naturally occurring
cytokine that is involved in normal inflammatory and immune
responses.1 Taltz inhibits the release of
pro-inflammatory cytokines and chemokines.1
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 www.lilly.com/newsroom/social-channels.
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
moderate-to-severe plaque psoriasis and active psoriatic arthritis,
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.
1 Taltz Prescribing Information, 2017.
2 Ritchlin C, et. al. Psoriatic Arthritis.
New England Journal of Medicine. 2017;376:957-70.
Refer to:
Courtney
Kasinger, ckasinger@lilly.com; 317-501-7056 (Lilly
media)
Phil Johnson;
johnson_philip_l@lilly.com; +1-317-655-6874 (Lilly investors)
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