Novartis' Cosentyx superior to Stelara in delivering long-lasting skin clearance (PASI 90) for psoriasis patients at 52 weeks
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Novartis International AG /
Novartis' Cosentyx superior to Stelara in delivering long-lasting skin clearance
(PASI 90) for psoriasis patients at 52 weeks
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* New data at AAD 2016 shows Cosentyx(® )is significantly more efficacious
than Stelara in sustaining skin clearance (PASI 90 to PASI 100) at 52
weeks[1]
* Cosentyx delivered and sustained skin clearance (PASI 90 to PASI 100) in
nearly 8 out of 10 moderate-to-severe psoriasis patients[1]
* Cosentyx granted first-line systemic indication for psoriasis in Europe and
recently approved in psoriatic arthritis and ankylosing spondylitis in the
US and Europe
The digital press release with multimedia content can be accessed here:
Basel, March 5, 2016 - Novartis announced today new late-breaking data from the
head-to-head CLEAR study, demonstrating that Cosentyx (secukinumab) remains
superior to Stelara (ustekinumab) in achieving sustained skin clearance (PASI
90 response) at 52 weeks for adults living with moderate-to-severe psoriasis.
These findings were presented for the first time at the American Academy of
Dermatology (AAD) Annual Meeting in Washington, DC[1].
Cosentyx is the first fully human interleukin-17A inhibitor approved for adults
to treat moderate-to-severe plaque psoriasis, and was recently approved for the
treatment of psoriatic arthritis and ankylosing spondylitis in the EU and US.
"Cosentyx continues to demonstrate superior and sustainable efficacy against
currently available biologics and is a proven first-line treatment option for
adult patients with moderate-to-severe psoriasis," said Vasant Narasimhan,
Global Head, Drug Development and Chief Medical Officer, Novartis. "Cosentyx has
the potential to give more people with psoriasis than ever before the benefit of
long-lasting skin clearance."
The ultimate aim of psoriasis treatment is clear skin, and the Psoriasis Area
Severity Index (PASI) 90 response is considered an important measure of
treatment success[2],[3]. Meeting all primary and secondary endpoints at Weeks
Four, 16 and 52, Cosentyx demonstrated it remains consistently superior to
Stelara in achieving and sustaining PASI 90 response (76.2% vs. 60.6%;
P<0.0001), and significantly better in achieving PASI 100 (clear skin) response
(45.9% vs. 35.8%; P=0.0103) at 52 weeks. Cosentyx also showed significantly
greater and sustained Dermatology Life Quality Index (DLQI) 0/1 responses versus
Stelara (71.6% vs. 59.2%; P=0.0008)[1].
The study also demonstrated Cosentyx had a superior rapid onset of action
compared to Stelara, with half of Cosentyx patients achieving PASI 75 as early
as Week Four (50.0% vs. 20.6%, P<0.0001)[4]. Cosentyx had a similar safety
profile to that of Stelara in the study, which was consistent with that reported
in the pivotal Cosentyx Phase III studies[1].
Affecting around 125 million people globally, psoriasis is a chronic skin
condition that causes itching, scaling and pain, and can have a significant
impact on physical and psychological wellbeing[5],[6]. Despite this, up to half
of patients receive no treatment, and of those who do, many (52%) remain
dissatisfied with their disease management[7].
About psoriasis
Psoriasis is a common, non-contagious, autoimmune disease that affects up to 3%
of the world's population[5]. Plaque psoriasis is the most common form of the
disease and appears as raised, red patches covered with a silvery white buildup
of dead skin cells. Psoriasis is not simply a cosmetic problem, but a
persistent, chronic (long-lasting), and sometimes distressing disease, which can
affect even the smallest aspects of people's lives on a daily basis. Up to 30%
of patients with psoriasis have, or will, develop psoriatic arthritis, in which
the joints are also affected, causing debilitating symptoms including pain,
stiffness and irreversible joint damage[8],[9]. Psoriasis is also associated
with other serious health conditions, such as diabetes, heart disease and
depression[8].
About the CLEAR study
CLEAR (Comparison to assess Long-term Efficacy, sAfety and toleRability of
secukinumab vs. ustekinumab) is a multi-center, double-blind, parallel-group
study of Cosentyx (n=334) versus Stelara (n=335) to compare efficacy, safety and
tolerability in adults with moderate-to-severe plaque psoriasis. Patients were
randomized to receive either Cosentyx (300 mg) by subcutaneous injection at
Baseline, Weeks One, Two and Three, then every four weeks from Week Four, or
Stelara (dosing per package label). Cosentyx achieved the primary objective of
superior PASI 90 response at Week 16. These data were published as an e-
publication in the Journal of the American Academy of Dermatology, June
17, 2015[4]. The 52-week PASI 90 response is a secondary objective in this
study. PASI 100 and DLQI responses at 52 weeks are exploratory endpoints.
About Cosentyx and interleukin-17A (IL-17A)
Cosentyx is a fully human monoclonal antibody that selectively neutralizes
circulating IL-17A. Research suggests that IL-17A may play an important role in
driving the body's immune response in psoriasis, psoriatic arthritis and
ankylosing spondylitis[10],[11].
Cosentyx is approved in over 50 countries for the treatment of moderate-to-
severe plaque psoriasis which includes the European Union countries, Japan,
Switzerland, Australia, the US and Canada. In Europe, Cosentyx is the only
biologic approved for the first-line systemic treatment of moderate-to-severe
plaque psoriasis in adult patients. In the US, Cosentyx is approved as a
treatment for moderate-to-severe plaque psoriasis in adult patients who are
candidates for systemic therapy or phototherapy (light therapy).
In addition, Cosentyx is the first IL-17A inhibitor with positive Phase III
results for the treatment of active psoriatic arthritis and active ankylosing
spondylitis[12]-[16] and is now approved in Europe, the US, Ecuador, Bangladesh
and the Philippines for these conditions. Cosentyx is also approved for the
treatment of psoriatic arthritis and pustular psoriasis in Japan.
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by words such as "continues," "potential," "aim," "can," "will," "suggests,"
"may," or similar terms, or by express or implied discussions regarding
potential new indications or labeling for Cosentyx, or regarding potential
future revenues from Cosentyx. You should not place undue reliance on these
statements. Such forward-looking statements are based on the current beliefs and
expectations of management regarding future events, and are subject to
significant known and unknown risks and uncertainties. Should one or more of
these risks or uncertainties materialize, or should underlying assumptions prove
incorrect, actual results may vary materially from those set forth in the
forward-looking statements. There can be no guarantee that Cosentyx will be
submitted or approved for any additional indications or labeling in any market,
or at any particular time. Nor can there be any guarantee that Cosentyx will be
commercially successful in the future. In particular, management's expectations
regarding Cosentyx could be affected by, among other things, the uncertainties
inherent in research and development, including unexpected clinical trial
results and additional analysis of existing clinical data; unexpected regulatory
actions or delays or government regulation generally; the company's ability to
obtain or maintain proprietary intellectual property protection; general
economic and industry conditions; global trends toward health care cost
containment, including ongoing pricing pressures; unexpected safety issues;
unexpected manufacturing or quality issues, and other risks and factors referred
to in Novartis AG's current Form 20-F on file with the US Securities and
Exchange Commission. Novartis is providing the information in this press release
as of this date and does not undertake any obligation to update any forward-
looking statements contained in this press release as a result of new
information, future events or otherwise.
About Novartis
Novartis provides innovative healthcare solutions that address the evolving
needs of patients and societies. Headquartered in Basel, Switzerland, Novartis
offers a diversified portfolio to best meet these needs: innovative medicines,
eye care and cost-saving generic pharmaceuticals. Novartis is the only global
company with leading positions in these areas. In 2015, the Group achieved net
sales of USD 49.4 billion, while R&D throughout the Group amounted to
approximately USD 8.9 billion (USD 8.7 billion excluding impairment and
amortization charges). Novartis Group companies employ approximately 119,000
full-time-equivalent associates. Novartis products are available in more than
180 countries around the world. For more information, please visit
http://www.novartis.com.
Novartis is on Twitter. Sign up to follow (at)Novartis at
http://twitter.com/novartis.
References
[1] Blauvelt A et al. Secukinumab demonstrates superior sustained efficacy vs.
ustekinumab in clearing skin of subjects with moderate to severe plaque
psoriasis: 52-week results from the CLEAR study. Abstract presented at the 74th
Annual Meeting of the American Academy of Dermatology. 2016 March 4-8;
Washington DC.
[2] Guideline on clinical investigation of medicinal products indicated for the
treatment of psoriasis. European Medicines Agency website. Available at:
http://www.ema.europa.eu/docs/en_GB/document_library/
Scientific_guideline/2009/09/WC500003329.pdf Accessed September 2015. Accessed
February 2016.
[3] Ryan C et al. Research gaps in psoriasis: opportunities for future studies.
J Am Acad Dermatol. 2014; 70:146-167.
[4] Thaçi D, Blauvelt A, Reich K, et al. Secukinumab is superior to ustekinumab
in clearing skin of subjects with moderate to severe plaque psoriasis: CLEAR, a
randomized controlled trial. J Am Acad Dermatol. June 17, 2015 [E-pub ahead of
print].
[5] International Federation of Psoriasis Associations (IFPA) World Psoriasis
Day website. "About Psoriasis." Available at:
http://www.worldpsoriasisday.com/web/page.aspx?refid=114. Accessed February
2016.
[6] Langley RG et al. Secukinumab in plaque psoriasis - results of two phase
three trials. N Engl J Med. 2014; 371(4):326-338.
[7] Armstrong AW et al. Undertreatment, treatment trends, and treatment
dissatisfaction among patients with psoriasis and psoriatic arthritis in the
United States: findings from the National Psoriasis Foundation surveys,
2003-2011. JAMA Dermatol. 2013; 149(10):1180-1185.
[8] National Psoriasis Foundation. Psoriatic disease: about psoriasis. Available
at: www.psoriasis.org/about-psoriasis. Accessed January 2016.
[9] Mease PJ, Armstrong AW. Managing patients with psoriatic disease: the
diagnosis and pharmacologic treatment of psoriatic arthritis in patients with
psoriasis. Drugs. 2014; 74:423-441.
[10] Kirkham BW et al. Interleukin-17A: a unique pathway in immune-mediated
diseases: psoriasis, psoriatic arthritis and rheumatoid arthritis. Immunology.
2014; 141:133-142.
[11] Ivanov S, Linden A. Interleukin-17 as a drug target in human disease.
Trends Pharmacol Sci. 2009; 30(2):95-103.
[12] Baeten D et al. Secukinumab, interleukin-17A inhibition in ankylosing
spondylitis. N Engl J Med. 2015; 373:2534-48.
[13] Mease, PJ et al. Secukinumab, a human anti-interleukin-17A monoclonal
antibody, in patients with psoriatic arthritis (FUTURE 2): a randomised, double-
blind, placebo-controlled, phase 3 trial. The Lancet. 2015; 386(9999):1137-1146.
[14] Mease PJ et al. Secukinumab inhibition of interleukin-17A in patients with
psoriatic arthritis. N Engl J Med. 2015; 373(14):1329-39.
[15] Cosentyx (secukinumab) [prescribing information]. East Hanover, NJ:
Novartis Pharmaceuticals Corp, 2016.
[16] Cosentyx Summary of Product Characteristics. Novartis Europharm Limited.
Available at:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/0037
29/human_med_001832.jsp&mid=WC0b01ac058001d124. Accessed February 2016.
# # #
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Datum: 05.03.2016 - 18:00 Uhr
Sprache: Deutsch
News-ID 455420
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