Novartis confirms 5 year data for first and only fully-human IL-17A inhibitor Cosentyx® reinforcing sustained efficacy and safety profile in psoriasis
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Novartis International AG /
Novartis confirms 5 year data for first and only fully-human IL-17A inhibitor
Cosentyx® reinforcing sustained efficacy and safety profile in psoriasis
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The issuer is solely responsible for the content of this announcement.
* 5 year data from long-term Phase III extension study demonstrate sustained
efficacy and safety of Cosentyx in patients with moderate-to-severe plaque
psoriasis[1]
* Data planned to be presented at a key medical congress in the second half of
2017. 5 year Phase III data is a recognized milestone for assessing long-
term efficacy and safety of innovative treatments
* Recently announced EU approval for Cosentyx label update underlined long-
term superiority versus Stelara(®*) in psoriasis, and efficacy in moderate-
to-severe scalp psoriasis[2],[3]
Basel, July 14, 2017 - Novartis, a global leader in Immunology & Dermatology,
confirmed today positive 5 year efficacy and safety results for Cosentyx® from a
Phase III long-term extension study in patients with moderate-to-severe plaque
psoriasis[1]. Data will be presented at a key medical congress in the second
half of 2017. 5 year Phase III data are a recognized milestone for assessing
long-term efficacy and safety of innovative treatments.
"Cosentyx has consistently demonstrated sustained efficacy and safety providing
psoriasis patients a new standard of long-term care," said Vas Narasimhan,
Global Head of Drug Development and Chief Medical Officer, Novartis. "With the
first data from a pivotal trial with 5 years of follow up, Cosentyx continues to
demonstrate it can provide what psoriasis patients want, a life with clear
skin."
4 year Phase III data presented at EADV 2016 showed Cosentyx delivered almost
clear or completely clear skin in a majority of patients (PASI 90 - 66%, PASI
100 - 44%) after 4 years of treatment[13]. The data showed that with Cosentyx,
97% of PASI 90 and 99% of PASI 100 response rates were maintained from Year 1 to
Year 4[13].
Recently, new label updates announced for Cosentyx in Europe demonstrated long-
term superiority of Cosentyx versus Stelara(®*) (ustekinumab) in moderate-to-
severe plaque psoriasis on the basis of 52 week data from the CLEAR study, and
expanded the use of Cosentyx for the treatment of moderate-to-severe scalp
psoriasis[2],[3]. Cosentyx was launched in 2015 as the first and only fully-
human IL-17A inhibitor to treat psoriasis and is now licenced for the treatment
of psoriatic arthritis and ankylosing spondylitis as well. Novartis remains
committed to investigating important scientific questions with Cosentyx that
address unmet needs and could significantly enhance patients' quality of life.
About the study
The long-term extension study for Cosentyx in patients with moderate-to-severe
psoriasis is designed to analyze efficacy and safety over the period of 5 years
(Week 260)[1]. The current data analysis for Cosentyx includes all patients who
reached a PASI 75 response at Week 12 and subsequently received continuous
treatment with 300mg secukinumab until the end of Year 5[1]. The study includes
analysis of the PASI 75/90/100 response rates over the extended treatment period
from Year 1 (Week 52) to the end of Year 5 (Week 260), analyses of body surface
area (BSA) and absolute PASI (i.e. assessments of increasing relevance to the
dermatologists), showing how many patients still on study drug had no more than
1% of their BSA covered by psoriasis, mean PASI and BSA improvement, as well as
the safety profile of Cosentyx[1].
About psoriasis
Psoriasis is a common, non-contagious, auto-immune disease that affects more
than 125 million people worldwide[4]. 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. Scalp psoriasis is a form of psoriasis that is
reported to affect approximately half of all patients with psoriasis[5]. The
disease has a significant impact on patients' quality of life, which is an
aspect of the disease underestimated by most physicians[6].
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, PsA[7]. PsA is a condition in which the joints are also
affected, causing debilitating symptoms including pain, stiffness and
irreversible joint damage[7],[8]. Psoriasis is also associated with other
serious health conditions, such as diabetes, heart disease and depression[7].
About Cosentyx and interleukin-17A (IL-17A)
Launched in January 2015, Cosentyx is a targeted treatment that specifically
inhibits the IL-17A cytokine. Research suggests that IL-17A may play an
important role in driving auto-inflammatory conditions in enthesis and
ultimately the body's immune response in psoriasis, psoriatic arthritis (PsA)
and ankylosing spondylitis (AS)[9],[10].
Cosentyx is approved in more than 75 countries for the treatment of moderate-to-
severe plaque psoriasis, which includes the US, Canada, the European Union
countries, Japan, Switzerland and Australia. In Europe, Cosentyx is approved for
the first-line systemic treatment of moderate-to-severe plaque psoriasis in
adult patients.[2] 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).[11]
Cosentyx is the first IL-17A inhibitor approved in more than 70 countries for
the treatment of active PsA and AS, which includes the US and the European Union
countries. Cosentyx is also approved for the treatment of PsA and pustular
psoriasis in Japan.[12]
Disclaimer
This press release contains forward-looking statements, including "forward-
looking statements" within the meaning of the United States Private Securities
Litigation Reform Act of 1995. Forward-looking statements can generally be
identified by words such as "potential," "can," "will," "plan," "expect,"
"anticipate," "look forward," "believe," "committed," "investigational,"
"pipeline," "launch," or similar terms, or by express or implied discussions
regarding potential marketing approvals, new indications or labeling for the
investigational or approved products described in this press release, or
regarding potential future revenues from such products. You should not place
undue reliance on these statements. Such forward-looking statements are based on
our current beliefs and expectations 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 the investigational
or approved products described in this press release will be submitted or
approved for sale or for any additional indications or labeling in any market,
or at any particular time. Nor can there be any guarantee that such products
will be commercially successful in the future. In particular, our expectations
regarding such products could be affected by, among other things, the
uncertainties inherent in research and development, including clinical trial
results and additional analysis of existing clinical data; regulatory actions or
delays or government regulation generally; our ability to obtain or maintain
proprietary intellectual property protection; the particular prescribing
preferences of physicians and patients; global trends toward health care cost
containment, including government, payor and general public pricing and
reimbursement pressures; general economic and industry conditions, including the
effects of the persistently weak economic and financial environment in many
countries; safety, quality or 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,
cost-saving generic and biosimilar pharmaceuticals and eye care. Novartis has
leading positions globally in each of these areas. In 2016, the Group achieved
net sales of USD 48.5 billion, while R&D throughout the Group amounted to
approximately USD 9.0 billion. Novartis Group companies employ approximately
118,000 full-time-equivalent associates. Novartis products are sold in
approximately 155 countries around the world. For more information, please visit
http://www.novartis.com.
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*Stelara® is a registered trademark of Janssen Biotech, Inc.
References
[1] Novartis, data on file
[2] Cosentyx Summary of Product Characteristics. Novartis Europharm Limited.
Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR-
Product_Information/human/003729/WC500183129.pdf. Last accessed July 2017.
[3] Blauvelt A et al. Secukinumab is superior to ustekinumab in clearing skin of
subjects with moderate-to-severe plaque psoriasis up to 1 year: Results from the
CLEAR study. Journal of the American Academy of Dermatology. 2017;76:60-69.
[4] International Federation of Psoriasis Associations (IFPA) World Psoriasis
Day website. "About Psoriasis." Available at:
http://www.worldpsoriasisday.com/web/page.aspx?refid=114. Last accessed June
2017.
[5] Farber EM, Nall L. Natural history and treatment of scalp psoriasis. Cutis.
1992;49:396-400.
[6] Wozel G. Psoriasis treatment in difficult locations: scalp, nails, and
intertriginous areas. Clinics in Dermatology. 2008;26:448-459.
[7] National Psoriasis Foundation. Psoriatic disease: about psoriasis. Available
at: www.psoriasis.org/about-psoriasis. Last accessed June 2017.
[8] 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.
[9] Kirkham BW et al. Interleukin-17A: a unique pathway in immune-mediated
diseases: psoriasis, psoriatic arthritis and rheumatoid arthritis. Immunology.
2014; 141:133-142.
[10] Ivanov S, Linden A. Interleukin-17 as a drug target in human disease.
Trends in Pharmacological Sciences. 2009; 30(2):95-103.
[11] Cosentyx (secukinumab) [prescribing information]. East Hanover, NJ:
Novartis Pharmaceuticals Corp, 2016.
[12] Novartis, data on file
[13] Bissonnette R et al. Secukinumab maintains high levels of efficacy through
4 years of treatments: results from an extension to a phase 3 study (SCULPTURE).
Presented as a late breaking abstract at the European Academy of Dermatology and
Venereology 2016. 1(st) October 2016.
# # #
Novartis Media Relations
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Source: Novartis International AG via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 14.07.2017 - 19:22 Uhr
Sprache: Deutsch
News-ID 552467
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contact information:
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