INDIANAPOLIS, May 2, 2016 /PRNewswire/ -- Eli Lilly and
Company (NYSE: LLY) announced today that
Taltz® (ixekizumab) injection 80 mg/mL for
the treatment of moderate-to-severe plaque psoriasis is now
available by prescription order through a contracted network of
specialty pharmacies in the United
States. Lilly is also offering patient support programs to
help ensure eligible patients have access to Taltz and available
resources.
Taltz was approved by the U.S. FDA in March 2016 for the treatment of
moderate-to-severe plaque psoriasis in adult patients who are
candidates for systematic therapy or phototherapy. Taltz should not
be used in patients with previous hypersensitivity reaction, such
as anaphylaxis, to ixekizumab or to any of the excipients. Taltz is
designed to specifically target IL-17A, a protein that plays a role
in driving underlying inflammation in psoriasis.1
In three pivotal studies, at 12 weeks, 87 to 90 percent of
patients treated with Taltz saw a significant improvement of their
psoriasis plaques (PASI 75). In addition, 81 to 83 percent of
patients treated with Taltz achieved sPGA 0 or 1. The majority of
patients treated with Taltz, 68 to 71 percent, achieved virtually
clear skin (PASI 90) and 35 to 42 percent of patients saw complete
resolution of their psoriasis plaques (PASI 100, sPGA 0). Among
those patients treated with placebo, 7 percent or fewer achieved
PASI 75, 7 percent or fewer achieved sPGA 0 or 1, 3 percent or
fewer achieved PASI 90 and 1 percent or fewer achieved PASI 100 and
sPGA 0.
Taltz may increase the risk of infection. In trials, the rate of
infection in the Taltz group was 27 percent vs. 23 percent in the
placebo group. 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,
monitor the patient closely and discontinue Taltz until the
infection resolves.
"Many people with moderate-to-severe plaque psoriasis are
searching for a treatment that will help them achieve high levels
of clear skin. With Taltz now available, physicians and patients
have a new treatment option that may help patients experience
virtually or completely clear skin," said Alex Azar, president, Lilly USA, LLC. "Lilly is committed to providing
education and resources to help make Taltz accessible to people
with moderate-to-severe plaque psoriasis."
The Taltz Together™ program will provide
interested patients with injection training, guidance on navigating
insurance benefits, and working with a contracted network of
specialty pharmacies to help fill Taltz prescriptions. Patients
will also have access to a Companion in Care™, a
personal patient representative to answer questions and concerns,
with each patient receiving attention from the same specialist
during each call. For more information about Taltz Together,
patients can contact 1-844-TALTZ-NOW
(1-844-825-8966).
"The availability of new treatments like Taltz is vitally
important for patients with moderate-to-severe plaque psoriasis,"
said Randy Beranek, president of the
National Psoriasis Foundation. "The effects of psoriasis can vary
among patients and what works for one patient may not work for
another. We are happy to see more options available so patients can
continue treating this very difficult disease."
The clinical program for Taltz included three double-blind,
multicenter, Phase 3 studies—UNCOVER-1, UNCOVER-2 and
UNCOVER-3—which demonstrated the safety and efficacy of Taltz in
patients with moderate-to-severe plaque psoriasis. All three
studies evaluated the safety and efficacy of Taltz (80 mg every two
weeks, following a 160-mg starting dose) compared to placebo after
12 weeks. UNCOVER-2 and UNCOVER-3 included an additional comparator
arm in which patients received U.S.-approved etanercept (50 mg
twice a week) for 12 weeks. UNCOVER-1 and UNCOVER-2 also evaluated
response rates with Taltz during the maintenance period through 60
weeks.
In these studies, the co-primary efficacy endpoints at 12 weeks
were a 75 percent improvement in the composite Psoriasis Area
Severity Index (PASI) score and static Physician's Global
Assessment (sPGA) 0 or 1 and at least a 2-point improvement from
baseline. PASI measures the extent and severity of psoriasis by
assessing average redness, thickness and scaliness of skin lesions
(each graded on a zero to four scale), weighted by the body surface
area of involved skin, while the sPGA is the physician's assessment
of severity of a patient's psoriasis lesions overall at a specific
point in time and is a required measure the FDA uses to evaluate
effectiveness.2
Taltz was also statistically superior to U.S.-approved
etanercept at all skin clearance levels, including PASI 75 and sPGA
0 or 1 at 12 weeks. In an integrated analysis of the U.S. sites in
the two active comparator studies—UNCOVER-2 and UNCOVER-3—the
respective response rates for Taltz vs. U.S.-approved etanercept
were 87 percent vs. 41 percent for PASI 75 and 73 percent vs. 27
percent for sPGA 0 or 1.
Information regarding the safety of Taltz is drawn from a
database of 4,204 patients with moderate-to-severe plaque psoriasis
who volunteered in both controlled and uncontrolled clinical
trials.
Other warnings and precautions for Taltz include pre-treatment
evaluation for tuberculosis, hypersensitivity reactions,
inflammatory bowel disease and immunizations. See Important Safety
Information below.
In UNCOVER-2 and UNCOVER-3, the rate of serious adverse events
during the controlled induction period (weeks 0-12) was 0.7 percent
for U.S.-approved etanercept and 2 percent for Taltz, and the rate
of discontinuation from adverse events was 0.7 percent for
U.S.-approved etanercept and 2 percent for Taltz. The incidence of
infections was 18 percent for U.S.-approved etanercept and 26
percent for Taltz. The rate of serious infections was 0.3 percent
for both U.S.-approved etanercept and Taltz.
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 indicated
for the treatment of adults with moderate-to-severe plaque
psoriasis who are candidates for systemic therapy or
phototherapy.
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.
The Taltz group had a higher rate of infections than the placebo
group (27% vs. 23%). 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. Patients receiving Taltz should be monitored closely 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. If a serious hypersensitivity
reaction occurs, discontinue Taltz immediately and initiate
appropriate therapy.
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. During Taltz treatment, monitor patients for onset or
exacerbations of inflammatory bowel disease.
Immunizations
Prior to initiating therapy with Taltz,
consider completion of all age-appropriate immunizations according
to current immunization guidelines. Live vaccines should not be
given 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.
Please see accompanying Prescribing Information
and Medication Guide. Please see
Instructions for Use included with the device.
IX HCP ISI 22MAR2016
About Taltz®
Taltz®
(ixekizumab) is a humanized IgG4 monoclonal antibody that
selectively binds with interleukin 17A (IL-17A) cytokine and
inhibits its interaction with the IL-17 receptor. 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.
About the UNCOVER Studies
The UNCOVER-1, UNCOVER-2 and
UNCOVER-3 studies are double-blind, multicenter, Phase 3 studies
evaluating more than 3,800 patients with moderate-to-severe
plaque psoriasis from 21 countries. All three studies evaluated the
safety and efficacy of different dosing regimens of Taltz (80 mg
every two or four weeks, following a 160-mg starting dose) compared
to placebo after 12 weeks. UNCOVER-2 and UNCOVER-3 included an
additional comparator arm in which patients received U.S.-approved
etanercept (50 mg twice a week) for 12 weeks. In UNCOVER-1 and
UNCOVER-2, safety and efficacy of Taltz was further evaluated
through 60 weeks.
About Moderate-to-Severe Plaque Psoriasis
Psoriasis is
a chronic, immune disease that affects the skin.3 It
occurs when the immune system sends out faulty signals that speed
up the growth cycle of skin cells.3 It is the most
common inflammatory disease in the United States, affecting as many as 7.5
million Americans and an estimated 125 million people
worldwide.3 The most common form of
psoriasis, plaque psoriasis, appears as raised, red patches covered
with a silvery white buildup of dead skin
cells.3 Approximately 20 percent of people with
psoriasis have moderate-to-severe plaque psoriasis.4
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 http://newsroom.lilly.com/social-channels.
P-LLY
Lilly Forward-Looking Statement
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 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-0483 04/2016 ©Lilly USA, LLC 2016. All rights reserved. Taltz® is
a registered trademark owned or licensed by Eli Lilly and Company,
its subsidiaries or affiliates. Taltz Together™ and Companion in
Care™ are registered trademarks of Eli Lilly and
Company.
_______________________________
1 Krueger JG, Fretzin S, Suárez-Fariñas M, et al. IL-17A
is essential for cell activation and inflammatory gene circuits in
subjects with psoriasis. J Allergy Clin
Immunol. 2012;130(1):145-54.
2 Feldman SR, Krueger GG. Psoriasis assessment tools in
clinical trials. Ann Rheum Dis. 2005;64:ii65-ii68.
http://ard.bmj.com/content/64/suppl_2/ii65.full. Accessed
April 22, 2016.
3 Psoriasis media kit. National Psoriasis Foundation
website.
https://www.psoriasis.org/sites/default/files/for-media/MediaKit.pdf.
Accessed April 22, 2016.
4 Psoriasis. American Academy of Dermatology website.
https://www.aad.org/media-resources/stats-and-facts/conditions/psoriasis.
Accessed April 22, 2016.
Refer to: J. Scott
MacGregor, jsmacgregor@lilly.com; 317-440-4699
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