Novartis' Cosentyx(TM) two-year data shows sustained effect and favorable safety profile in psoriasis patients
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Novartis' Cosentyx(TM) two-year data shows sustained effect and favorable safety
profile in psoriasis patients
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* After two full years of therapy with Cosentyx 300 mg, almost 9 out of 10
psoriasis patients sustained their PASI 75 response[1]
* New data at AAD shows 7 out of 10 psoriasis patients, who were PASI 75
responders at 52 Weeks, had almost clear to clear skin (PASI 90 to PASI
100) after two years of Cosentyx 300 mg treatment[1]
* Cosentyx is the first and only IL-17A inhibitor approved in Europe, the US,
Japan, Canada and Switzerland for moderate-to-severe plaque
psoriasis[2],[3],[4]
The digital press release with multimedia content can be accessed here:
Basel, March 21, 2015 - Novartis today announced new two-year results
demonstrating strong and sustained efficacy with Cosentyx(TM) (secukinumab) with
a favorable safety profile for the treatment of psoriasis patients[1]. The data
comes from the extension study of the pivotal Phase III FIXTURE and ERASURE
trials. Results were presented for the first time in a late-breaking session at
the 73rd Annual Meeting of the American Academy of Dermatology (AAD) in San
Francisco, USA. Cosentyx is the first and only interleukin-17A (IL-17A)
inhibitor approved to treat adult moderate-to-severe plaque psoriasis patients.
In this extension of the FIXTURE and ERASURE studies, 995 patients who achieved
Psoriasis Area Severity Index (PASI) 75 response after a year of therapy (Week
52) received either Cosentyx 300 mg, Cosentyx 150 mg or placebo for an
additional year (Week 104)[1]. After two full years of therapy, 7 out of 10
(71%) patients treated with Cosentyx 300 mg had clear or almost clear skin (PASI
90); 4 out of 10 (44%) had clear skin (PASI 100) and almost 9 out of 10 (88%)
patients maintained their PASI 75 response[1]. PASI assesses treatment efficacy
by measuring the reduction in redness, scaling and thickness of psoriatic
plaques and the extent of involvement in each region of the body[5],[6].
"We are pleased to share new long term data showing how the sustained efficacy
and favorable safety profile of Cosentyx helps psoriasis patients maintain clear
or almost clear skin over two years of treatment," said Vasant Narasimhan,
Global Head of Development, Novartis Pharmaceuticals. "Psoriasis is a chronic
condition causing itching, scaling and pain; patients need therapies that
provide rapid relief and clear skin over a long period of time."
In the study, 70% of patients who initially received placebo and were switched
to receive Cosentyx 300 mg after losing treatment response, were able to achieve
PASI 90 within 12 weeks of starting Cosentyx treatment[1]. The safety profile of
Cosentyx was favorable and consistent with previously reported Phase III
clinical trials. No new or unexpected safety findings were identified during the
two year extension[1]. The most common adverse were nasopharyngitis, upper
respiratory tract infection, hypertension, headache and arthralgia.
About the A2302E1 Extension Study (Cosentyx Extension Study to the FIXTURE and
ERASURE studies)
A2302E1 is a multicenter, double-blind, randomized withdrawal extension study to
the FIXTURE and ERASURE pivotal Phase III studies. The extension study was
conducted to collect long term efficacy, safety and tolerability data on
Cosentyx in patients who achieved a PASI 75 response to Cosentyx at Week 52 of
the FIXTURE and ERASURE core studies in moderate-to-severe plaque psoriasis.
Patients who had been receiving Cosentyx 300 mg or 150 mg during the maintenance
period of the core studies, and who exhibited a PASI 75 response at Week 52 of
the core studies, were randomized to continue the same Cosentyx dose or receive
placebo[1]. Patients who exhibited partial response (PASI 50 to
enter A2302E, but did not enter the randomized withdrawal extension study[1].
Partial responders instead continued the same treatment dose (Cosentyx 300 mg or
150 mg) that they received at the time of completing the maintenance period
(Week 52) in the core studies. Non-responders (patients who did not achieve at
least a PASI 50 response at Week 52 of the core study) were not eligible to
enter any part of this extension study[1].
About the FIXTURE and ERASURE studies
FIXTURE (the Full year Investigative eXamination of secukinumab vs. eTanercept
Using 2 dosing Regimens to determine Efficacy in psoriasis) and ERASURE
(Efficacy of Response And Safety of two fixed secUkinumab REgimens in psoriasis)
are part of one of the largest Phase III program in moderate-to-severe plaque
psoriasis completed to date, which involved more than 3,300 patients in over 35
countries[7].
FIXTURE and ERASURE assessed the efficacy, safety and tolerability of induction
period (at Week 12) and maintenance therapy (at Week 52) with subcutaneous
Cosentyx 300 mg or 150 mg in patients with moderate-to-severe plaque
psoriasis[7]. Both studies were multicenter, randomized, double-blind, placebo-
controlled (FIXTURE: also active controlled), parallel-group Phase III trials
involving 1,306 patients and 738 patients with moderate-to-severe plaque
psoriasis, respectively[7]. Each study consisted of a 1-to-4-week screening
period, a 12-week induction period, a 40-week maintenance period and an 8-week
follow-up period[7]. FIXTURE was the first full-year blinded, direct comparison
of biologic therapies for psoriasis in a Phase III study[7].
The co-primary endpoints in both studies, PASI 75 response and Investigator's
Global Assessment (IGA mod 2011) 0/1 response at Week 12, were used to
demonstrate superiority of Cosentyx vs. placebo (p<0.001 for all
comparisons)[7]. Cosentyx 300 mg demonstrated significant improvements in PASI
75 at Week 12 (77.1% vs. 44.0% for Enbrel(®* )vs. 4.9% for placebo in FIXTURE
and 81.6% vs. 4.5% for placebo in ERASURE)[7].
About Cosentyx (secukinumab) and interleukin-17A (IL-17A)
Cosentyx is a human monoclonal antibody that selectively neutralizes
interleukin-17A (IL-17A)[8],[9]. IL-17A is found in high concentrations in skin
affected by psoriasis and is a preferred target for investigational
therapies[8]-[13]. Cosentyx works by inhibiting the action of IL-17A, a protein
found in high concentrations in skin affected by the disease[8]-[13]. In the
Phase III program, Cosentyx demonstrated a favorable safety profile, with
similar incidence and severity of adverse events between Cosentyx treatment arms
(300 mg and 150 mg)[1],[7].
In January 2015, Cosentyx (at a dose of 300 mg) became the first and only IL-
17A inhibitor approved in Europe as a first-line systemic treatment of moderate-
to-severe plaque psoriasis in adult patients, and in the US as a treatment for
moderate-to-severe plaque psoriasis in adult patients who are candidates for
systemic therapy or phototherapy (light therapy). In addition to the EU and the
US, Cosentyx has been approved in Switzerland, Chile, Australia, Canada and
Singapore for the treatment of moderate-to-severe plaque psoriasis and in Japan
for the treatment of moderate-to-severe plaque psoriasis and active psoriatic
arthritis (PsA).
Cosentyx is also in Phase III development for PsA and ankylosing spondylitis
(AS); global regulatory applications are planned for 2015.
About psoriasis
Psoriasis is a chronic immune-mediated disease characterized by thick and
extensive skin lesions, called plaques, known to cause itching, scaling and
pain; it is associated with significant impairment of physical and psychological
quality of life[14],[15],[16]. Psoriasis affects up to 3% of the world's
population, or more than 125 million people[17].
This common and distressing condition is not simply a cosmetic problem - even
people with very mild symptoms are affected everyday[2]. According to an
analysis of surveys conducted of 5,600 patients by the National Psoriasis
Foundation (NPF) between 2003 and 2011, 52% of patients with mild, moderate and
severe psoriasis were dissatisfied with their disease management[18]. Of the
patients surveyed, some were receiving no treatment (9.4-49.2%) or were
undertreated (10.2-55.5%)[18].
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by words such as "investigational," "planned," or similar terms, or by express
or implied discussions regarding potential additional marketing authorizations
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 for sale in any additional markets,
or approved for any additional indications, 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 manufacturing 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 2014, the Group achieved net
sales of USD 58 billion, while R&D throughout the Group amounted to
approximately USD 9.9 billion (USD 9.6 billion excluding impairment and
amortization charges). As of December 31, 2014 Novartis Group companies employed
approximately 133,000 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.
*Enbrel(®) is a registered trademark of Amgen Inc. Enbrel used in the FIXTURE
study was European sourced.
References
[1] Secukinumab Treatment Maintains Efficacy in Moderate to Severe Plaque
Psoriasis Through Second Year of Treatment: A Randomized Extension of the
ERASURE and FIXTURE Studies
[2] Papp KA, Langley RG, Sigurgeirsson B, et al. Efficacy and safety of
secukinumab in the treatment of moderate-to-severe plaque psoriasis: a
randomized, double-blind, placebo-controlled phase II dose-ranging study. Brit J
Dermatol. 2013; 168(2): 412-421.
[3] Rich PA, Sigurgeirsson B, Thaci D, et al. Secukinumab induction and
maintenance therapy in moderate to-severe plaque psoriasis: a randomized,
double-blind, placebo-controlled, phase II regimen-finding study. Brit J
Dermatol. 2013; 168(2): 402-411.
[4] Ohtsuki, M., Morita, A., Abe, M., et al. Secukinumab efficacy and safety in
Japanese patients with moderate-to-severe plaque psoriasis: Subanalysis from
ERASURE, a randomized, placebo-controlled, phase 3 study. The Journal of
Dermatology, 41: 1039-1046. doi: 10.1111/1346-8138.12668
[5] Guideline on clinical investigation of medicinal products indicated for the
treatment of psoriasis. European Medicines Agency Web site.
http://www.ema.europa.eu/docs/en_GB/document_library/
Scientific_guideline/2009/09/WC500003329.pdf Published November 2004. Accessed
January 2015.
[6] Mrowietz, U. Implementing treatment goals for successful long-term
management of psoriasis. Journal of the European Academy of Dermatology and
Venereology, 26: 12-20. doi: 10.1111/j.1468-3083.2011.04411.x
[7] Langley RG, Elewski BE, Lebwohl M, et al. Secukinumab in plaque psoriasis:
results of two phase three trials. N Engl J Med. 2014. Jul 9;371(4):326-38.
[8] Gaffen SL. Structure and signaling in the IL-17 receptor family. Nat Rev
Immunol. 2009;9(8):556-67.
[9] Ivanov S, Linden A. Interleukin-17 as a drug target in human disease. Trends
Pharmacol Sci. 2009;30(2):95-103.
[10] Kopf M, Bachmann MF, Marsland BJ. Averting inflammation by targeting the
cytokine environment. Nat Rev Drug Discov. 2010; 9(9):703-18.
[11] Onishi RM, Gaffen SL. Interleukin-17 and its target genes: mechanisms of
interleukin-17 function in disease. Immunology. 2010;129(3):311-21.
[12] Krueger J, 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):145-154.
[13] Johansen C, Usher PA, Kjellerup RB, et al. Characterization of the
interleukin-17 isoforms and receptors in lesional psoriatic skin. Brit J
Dermatol. 2009;160(2):319-24.
[14] Stern RS, Nijsten T, Feldman S, et al. Psoriasis Is Common, Carries a
Substantial Burden Even When Not Extensive, and Is Associated with Widespread
Treatment Dissatisfaction. J Investig Dermatol Symp. 2004;9(2):136-9.Nestle FO,
Kaplan DH, Barker J. Psoriasis. N Engl J Med. 2009; 361(5):496-509.
[15] Rapp SR, Feldman SR, Exum ML, Fleischer AB, Jr., Reboussin DM. Psoriasis
causes as much disability as other major medical diseases. J Am Acad Dermatol.
1999; 41(3 Pt 1):401-7.
[16] Farley E et al. Psoriasis: comorbidities and associations. G Ital Dermatol
Venereol. 2011 Feb;146(1):9-15.
[17] International Federation of Psoriasis Associations (IFPA) World Psoriasis
Day website. "About Psoriasis."
http://www.worldpsoriasisday.com/web/page.aspx?refid=114. Accessed February
2014.
[18] Armstrong AW, Robertson AD, Wu J, Schupp C, Lebwohl MG. 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.
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