INDIANAPOLIS, May 22, 2018 /PRNewswire/ -- Eli Lilly and
Company (NYSE: LLY) announced today that the U.S. Food and Drug
Administration (FDA) has approved a label update for
Taltz® (ixekizumab) injection 80 mg/mL to include
data in psoriasis involving the genital area.1 Taltz is
the first and only treatment approved by the FDA for
moderate-to-severe plaque psoriasis that includes such data in its
label.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 In
December 2017, Taltz was also
approved for the treatment of adults with active psoriatic
arthritis.1
"Up to 63 percent of psoriasis patients will be impacted by
psoriasis involving the genital area over the course of their
disease," said Pete Salzmann, vice
president, Lilly Immunology. "However, there remains a serious
unmet need for patients seeking treatment options. We are proud of
this important milestone for Taltz, and remain committed to
pursuing research that may improve outcomes for people living with
this challenging disease."
"It is common for patients with psoriasis to experience symptoms
in the genital area at some point during the course of their
disease," said Michael Siegel,
Ph.D., senior vice president of research and clinical affairs,
National Psoriasis Foundation. "This news is a significant step in
providing patients with more options for treating their disease. We
encourage patients to talk with their healthcare provider about
their symptoms of psoriasis in the genital area."
The label update is based on positive results from the first
randomized, double-blind, placebo-controlled study in
moderate-to-severe psoriasis involving the genital
area.1 In the study, 149 patients with plaque psoriasis
who were candidates for phototherapy or systemic therapy, and who
failed to respond to or were intolerant of at least one topical
therapy for the treatment of psoriasis affecting the genital area,
were treated with Taltz or placebo.1 Patients were
required to have a minimum body surface area involvement of 1
percent, a static Physician Global Assessment (sPGA) score of ≥3
and a sPGA of genitalia score of ≥3.1
Taltz demonstrated a significant improvement compared to placebo
at 12 weeks in the severity of psoriasis affecting the genital
area, as measured by sPGA of genitalia score; overall psoriasis, as
measured by sPGA score; genital itch, as measured by the Genital
Psoriasis Symptoms Scale (GPSS) Itch numeric rating scale (NRS);
and in the patient-perceived impact of psoriasis involving the
genital area on frequency of sexual activity, as measured by Sexual
Frequency Questionnaire (SFQ) Item 2 (In the past week how often
did your psoriasis involving the genital area limit the frequency
of your sexual activity?) score.1
- sPGA of genitalia score of "0" (clear) or "1" (minimal): 73
percent of patients treated with Taltz compared to 8 percent for
placebo1
- Overall sPGA score of "0" (clear) or "1" (minimal): 73 percent
of patients treated with Taltz compared to 3 percent for
placebo1
- GPSS Genital Itch (≥4 point improvement): 55 percent of
patients treated with Taltz compared to 6 percent for
placebo1
- SFQ Item 2 score "0" (never) or "1" (rarely): 78 percent of
patients treated with Taltz compared to 21 percent for
placebo1
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 The safety outcomes from this study were
consistent with the overall safety profile of Taltz.1
See Important Safety Information below.1
"Psoriasis involving the genital area can significantly impact
patients, yet it's not routinely examined by healthcare providers,"
said Caitriona Ryan, M.D., lead
study investigator. "The results from this clinical trial may raise
awareness around the topic among healthcare providers."
"The trial results found that the majority of patients treated
with Taltz achieved clear or almost clear genital skin at week 12,"
said Jennifer Clay Cather, M.D.,
Modern Research Associates, Dallas,
Texas. "With these data, physicians can recommend Taltz as
an effective treatment option for psoriasis in this area."
Indications and Usage
Taltz is approved to treat adults with moderate-to-severe plaque
psoriasis who are candidates for systemic therapy or
phototherapy.1 Taltz is also approved for the treatment
of adults with active psoriatic arthritis.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 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 Moderate-to-Severe Plaque Psoriasis
Psoriasis is
a chronic, immune disease that affects the skin.2 It
occurs when the immune system sends out faulty signals that speed
up the growth cycle of skin cells.2 Psoriasis affects
approximately 125 million people worldwide, approximately 20
percent of whom have moderate-to-severe plaque
psoriasis.2,3 Psoriasis can occur on any part of the
body, including the genital area.2 Up to 63 percent of
psoriasis patients experience genital psoriasis over the course of
their disease.4 The most common form of psoriasis,
plaque psoriasis, appears as raised, red patches covered with a
silvery white buildup of dead skin cells.2 Patients with
plaque psoriasis often have other serious health conditions, such
as diabetes and heart disease.2
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) in patients with moderate-to-severe
plaque psoriasis, who also have psoriasis in the genital area, and
reflects Lilly's current belief. Lilly considers patients with
genital psoriasis as a sub-population of patients with
moderate-to-severe plaque psoriasis. 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 future study results will be
consistent with the results to date, 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,
2018.
2 Psoriasis media kit. National Psoriasis Foundation website.
https://www.psoriasis.org/sites/default/files/for-media/MediaKit.pdf.
Last Updated May 22, 2018. Accessed
May 22, 2018.
3 Skin conditions by the numbers. American Academy of
Dermatology website.
https://www.aad.org/media/stats/conditions/skin-conditions-by-the-numbers.
Last Updated May 22, 2018. Accessed
May 22, 2018.
4 Ryan C, et al. J Am Acad Dermatol. 2015; 978-983.
PP-IX-US-2099 05/2018 ©Lilly USA, LLC 2018. All rights reserved.
Refer to:
|
Alison Barnes;
barnes_alison_g@lilly.com; 317-296-0615 (media)
|
|
Kevin Hern;
hern_kevin_r@lilly.com; 317-277-1838 (investors)
|
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