-
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.
Novartis is on Twitter. Sign up to follow
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For Novartis multimedia content, please visit
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For questions about the site or required registration, please
contact media.relations@novartis.com
*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. 1st October
2016.
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