Secukinumab (AIN457) showed superiority over Enbrel® in clearing skin, according to pivotal Novartis Phase III psoriasis results at EADV
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Novartis International AG /
Secukinumab (AIN457) showed superiority over Enbrel® in clearing skin, according
to pivotal Novartis Phase III psoriasis results at EADV
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* Secukinumab (AIN457) patients' skin cleared faster and for longer than
Enbrel(®) (etanercept) patients, beginning as early as Week 2[1]
* Study also showed twice as many secukinumab patients experienced clear or
almost clear skin by Week 12 versus Enbrel[1]
* Head-to-head study of secukinumab and Enbrel part of largest clinical
program completed in moderate-to-severe plaque psoriasis with more than
3,300 patients
* Secukinumab is the first IL-17A inhibitor with Phase III data and is on
track to be the first psoriasis medication filed targeting IL-17A
Basel, October 3, 2013 - Novartis announced today results from the head-to-head
Phase III FIXTURE study showing secukinumab (AIN457), an interleukin-17A (IL-
17A) inhibitor, was significantly superior to Enbrel(®)* (etanercept) in
moderate-to-severe plaque psoriasis[1]. Enbrel is a current standard-of-care
anti-TNF medication approved to treat moderate-to-severe plaque psoriasis. These
new results were presented today at the 22(nd) Congress of the European
Association of Dermatology and Venereology (EADV) in Istanbul, Turkey[1].
The pivotal FIXTURE study met all primary and pre-specified key secondary
endpoints(p<0.0001 for placebo comparisons and p=0.0250 for Enbrel
comparisons)[1]. Both doses of secukinumab showed improved efficacy to Enbrel
throughout the 52 week study, beginning as early as Week 2 and confirmed by Week
12 when the primary endpoints were assessed[1]. Importantly, more secukinumab
patients experienced almost clear skin (described as PASI 90) and completely
clear skin (PASI 100) compared to Enbrel[1], which are higher standards of skin
clearance compared to the standard efficacy measures used in most psoriasis
clinical studies.
"These exciting data suggest that with secukinumab, we have the potential to
help more patients achieve clear skin, which is the ultimate treatment goal,"
said David Epstein, Head of the Pharmaceuticals Division of Novartis Pharma AG.
"The data also show that specifically targeting IL-17A may offer a new and
effective treatment approach for people living with moderate-to-severe plaque
psoriasis."
FIXTURE compared two doses of secukinumab (300 mg and 150 mg) with Enbrel 50 mg
and placebo[1]. The co-primary endpoints were assessed at Week 12 and compared
secukinumab efficacy versus placebo according to the Psoriasis Area and Severity
Index 75 (PASI 75) and the Investigator's Global Assessment (IGA mod 2011)[1].
The study also showed that 72% of secukinumab 300 mg patients experienced at
least a 90% reduction in skin redness, thickness and scaling (PASI 90)[1] by
Week 16 of the study. More than half (54%) of secukinumab 300 mg patients
achieved PASI 90 as early as Week 12, compared to 21% of Enbrel patients[1].
Secukinumab 300 mg patients were also more likely to experience completely clear
skin compared to those taking Enbrel in the study, as measured by PASI 100 at
Week 12 (24% versus 4%)[1].
Secukinumab-treated patients also had their symptoms resolved faster than those
treated with Enbrel in the study[1]. Clinically relevant differences were
observed as early as Week 2, and on average secukinumab 300 mg patients had
their symptoms halved by Week 3, compared to Week 8 for Enbrel patients[1].
Secukinumab efficacy was sustained over the full one year duration of the study.
In FIXTURE, nearly twice as many patients treated with secukinumab 300 mg had a
PASI 90 response at Week 52 compared to Enbrel (65% vs. 33%)[1].
There were no major safety signals identified in FIXTURE or the broader
secukinumab Phase III clinical trial program in moderate-to-severe plaque
psoriasis. In FIXTURE, the incidence of adverse events (AEs) was similar between
both secukinumab treatment arms (300 mg and 150 mg), and was comparable to
Enbrel[1]. The most common AEs in any treatment group (including placebo)
throughout the 52 week treatment period were nasopharyngitis and headache
(occurring in between 12-36 patients per 100 patient years in all groups)[1]. At
the same time point, serious AEs (SAEs) were experienced by 6% of secukinumab
300 mg, 5% of secukinumab 150 mg and 6% of Enbrel patients[1]. There were no
deaths reported during the study[1].
Secukinumab is the first therapy selectively targeting IL-17A to have Phase III
results presented. IL-17A is a central cytokine (messenger protein) involved in
the development of psoriasis, and is found in high concentrations in psoriasis
skin plaques[2]-[4]. Research shows that IL-17A, in particular, plays a key role
in driving the body's autoimmune response in disorders such as moderate-to-
severe plaque psoriasis and is a preferred target for investigational
therapies[2]-[6].
Nearly 3% of the world's population, or more than 125 million people, are
affected by plaque psoriasis[7]. This is a common and debilitating disease -
even those with very mild symptoms find their condition affects their everyday
lives[8]. Psoriasis is also associated with psychosocial effects and those with
more severe disease are at a greater risk of death from comorbid diseases such
as heart disease and diabetes[9],[10].
Novartis announced top-line results from the FIXTURE study earlier this year.
FIXTURE forms part of the robust secukinumab Phase III clinical trial program in
moderate-to-severe plaque psoriasis that involved more than 3,300 patients in
over 35 countries worldwide. Regulatory submissions of secukinumab in moderate-
to-severe plaque psoriasis remain on track in the EU and US for the second half
of 2013.
About FIXTURE and the secukinumab data presented at EADV
FIXTURE (the Full year Investigative eXamination of secukinumab vs. eTanercept
Using 2 dosing Regimens to determine Efficacy in psoriasis) was a randomized
double-blind, placebo-controlled, multicenter, global pivotal Phase III
registration study involving 1,306 patients.
The co-primary endpoints were assessed at Week 12 and compared secukinumab
efficacy versus placebo according to PASI 75 and IGA mod 20111. These endpoints
were used also to demonstrate superiority of secukinumab vs. etanercept.
Secondary measures included PASI 50, 75, 90 and 100 at different time points. In
addition, the likelihood of loss of response at Week 52 was calculated by
determining the proportion of patients who lost PASI 75 at Week 52, after
initially achieving it at Week 12[1].
Data from an additional Phase III study of secukinumab in moderate-to-severe
plaque psoriasis was also presented today at EADV[13]. The SCULPTURE (Study
Comparing secukinumab Use in Long-term Psoriasis maintenance therapy: fixed
regimens vs reTreatment Upon start of RElapse) trial found that patients who
initially achieved PASI 75 at Week 12 were more likely to maintain their
response if they received secukinumab at fixed monthly intervals, compared to
treatment only on 'start of relapse'[13]. Results of two additional studies will
also become available tomorrow.
About secukinumab (AIN457)
Secukinumab (AIN457) is a fully human IgG1 monoclonal antibody that selectively
binds to and neutralizes IL-17A, a key pro-inflammatory cytokine[2]-[4]. Proof-
of-concept and Phase II studies in moderate-to-severe plaque psoriasis and
arthritic conditions (psoriatic arthritis, ankylosing spondylitis and rheumatoid
arthritis) have suggested that secukinumab may potentially provide a new
mechanism of action for the successful treatment of immune-mediated
diseases[14]-[18]. Phase III results from two additional Phase III studies in
moderate-to-severe plaque psoriasis will be presented in 2014, and in 2014 and
beyond for arthritic conditions. Phase II studies are also ongoing in other
areas, including multiple sclerosis.
About Novartis in specialty dermatology
Novartis is committed to developing innovative, life-changing specialty
dermatology therapies redefining treatment paradigms and transforming patient
care in severe skin diseases where there are remaining high unmet medical needs.
The Novartis specialty dermatology portfolio includes two unique targeted
products in Phase III development, secukinumab for moderate-to-severe plaque
psoriasis and omalizumab (Xolair(®)) for chronic spontaneous urticaria (CSU).
There are also more than 10 compounds in early stage development for a wide
range of severe skin diseases in the Novartis specialty dermatology portfolio.
For more information about the Novartis commitment to specialty dermatology,
visit: www.skintolivein.com.
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by terminology such as "on track," "suggest," "potential," "goal," "may,"
"investigational," "on-track," "suggested," "potentially," "will," "ongoing,"
"committed," or similar expressions, or by express or implied discussions
regarding potential marketing submissions or approvals for secukinumab (AIN457),
potential submissions or approvals for new indications or labeling for Xolair,
or regarding potential future revenues from such products. You should not place
undue reliance on these statements. Such forward-looking statements reflect the
current views of management regarding future events, and involve known and
unknown risks, uncertainties and other factors that may cause actual results to
be materially different from any future results, performance or achievements
expressed or implied by such statements. There can be no guarantee that
secukinumab (AIN457) will be submitted or approved for sale in any market, or at
any particular time. Nor can there be any guarantee that Xolair will be
submitted or approved for any additional indications or labeling in any market.
Neither can there be any guarantee that such products will achieve any
particular levels of revenue in the future. In particular, management's
expectations regarding these products could be affected by, among other things,
unexpected clinical trial results, including unexpected new clinical data and
unexpected additional analysis of existing clinical data; unexpected regulatory
actions or delays or government regulation generally; competition in general;
government, industry and general public pricing pressures; unexpected
manufacturing issues; the company's ability to obtain or maintain patent or
other proprietary intellectual property protection; the impact that the
foregoing factors could have on the values attributed to the Novartis Group's
assets and liabilities as recorded in the Group's consolidated balance sheet,
and other risks and factors referred to in Novartis AG's current Form 20-F on
file with the US Securities and Exchange Commission. Should one or more of these
risks or uncertainties materialize, or should underlying assumptions prove
incorrect, actual results may vary materially from those anticipated, believed,
estimated or expected. 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, cost-saving generic pharmaceuticals, preventive vaccines and
diagnostic tools, over-the-counter and animal health products. Novartis is the
only global company with leading positions in these areas. In 2012, the Group
achieved net sales of USD 56.7 billion, while R&D throughout the Group amounted
to approximately USD 9.3 billion (USD 9.1 billion excluding impairment and
amortization charges). Novartis Group companies employ approximately 131,000
full-time-equivalent associates and operate in more than 140 countries around
the world. For more information, please visit http://www.novartis.com.
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*Enbrel(®) is a registered trademark of Amgen Inc.
References
[1] Langley R, FIXTURE oral presentation at EADV.
[2] Gaffen SL. Structure and signaling in the IL-17 receptor family. Nat Rev
Immunol. 2009; 9(8):556-67.
[3] Ivanov S, Linden A. Interleukin-17 as a drug target in human disease. Trends
Pharmacol Sci. 2009; 30(2):95-103.
[4] Kopf M, Bachmann MF, Marsland BJ. Averting inflammation by targeting the
cytokine environment. Nat Rev Drug Discov. 2010; 9(9):703-718.
[5] Onishi RM, Gaffen SL. Interleukin-17 and its target genes: mechanisms of
interleukin-17 function in disease. Immunology. 2010; 129(3):311-321.
[6] 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.
[7] International Federation of Psoriasis Associations (IFPA) World Psoriasis
Day website. "About Psoriasis."
http://www.worldpsoriasisday.com/web/page.aspx?refid=114. Accessed August 2013.
[8] Mason AR, Mason J, Cork M et al. Topical treatments for chronic plaque
psoriasis. Cochrane Database Syst Rev. 2009;15;(2):CD005028.
[9] Abuabara K, Azfar RS, Shin DB, Neimann AL, Troxel AB, Gelfand JM. Cause-
specific mortality in patients with severe psoriasis: a population-based cohort
study in the U.K. Br J Dermatol. 2010 Sep;163(3):586-592
[10] Gelfand JM, Troxel AB, Lewis JD, Kurd SK, Shin DB, Wang X, Margolis DJ,
Strom BL. The risk of mortality in patients with psoriasis: results from a
population-based study. Arch Dermatol. 2007 Dec;143(12):1493-1499.
[11] Papp KA, Tyring S,Lahfa M, et al._A global phase III randomized controlled
trial of etanercept in psoriasis: safety, efficacy, and effect of dose
reduction. Br J Dermatol 2005;152:1304-1312.
[12]Leonardi CL, Powers JL, Matheson RT, et al. Etanercept as monotherapy in
patients with psoriasis. NEJM 2003;349:2014-2022.
[13] SCULPTURE oral presentation at EADV.
[14] 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. BJD
2013; 168, pp412-421.
[15] 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. BJD
2013;168: 402-411.
[16] Genovese MC, Durez P, Richards HB, et al. Efficacy and safety of
secukinumab in patients with rheumatoid arthritis: a phase II, dose-finding,
double-blind, randomised, placebo controlled study. Ann Rheum Dis
2013;72:863-869.
[17] Baeten D, Sieper J, Emery P, et al. The anti-il17a monoclonal antibody
secukinumab (AIN457) showed good safety and efficacy in the treatment of active
ankylosing spondylitis. At: EULAR 2011, The Annual European Congress of
Rheumatology, 25-28 May 2011, London, UK. Abstract 0174.
[18] McInnes IB, Sieper J, Braun J, et al. Efficacy and safety of secukinumab, a
fully human anti-interleukin-17A monoclonal antibody, in patients with moderate-
to-severe psoriatic arthritis: a 24-week, randomised, double-blind, placebo-
controlled, phase II proof-of-concept trial. Ann Rheum Dis 2013 Jan 29;
doi:10.1136/annrheumdis-2012-202646.
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