Novartis receives approval in the EU for Cosentyx label update, includes long term superiority data versus Stelara in psoriasis
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Novartis International AG /
Novartis receives approval in the EU for Cosentyx label update, includes long
term superiority data versus Stelara in psoriasis
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The issuer is solely responsible for the content of this announcement.
* Label update includes 52 week data from CLEAR study demonstrating long-term
superiority of Cosentyx(®) versus Stelara(® )in psoriasis [1],[2]
* Update also includes use of Cosentyx in moderate-to-severe scalp
psoriasis[1] - one of the most difficult-to-treat types of psoriasis[3]
* Cosentyx is the first interleukin-17A (IL-17A) inhibitor approved to treat
psoriasis, psoriatic arthritis (PsA) and ankylosing spondylitis (AS)
The digital press release with multimedia content can be accessed here:
Basel, July 06, 2017 - Novartis announced today that the Committee for Medicinal
Products for Human Use (CHMP) has approved a label update for Cosentyx(®)
(secukinumab), the first interleukin-17A (IL-17A) approved to treat psoriasis.
The label update includes 52 week data from the CLEAR study demonstrating the
long-term superiority of Cosentyx versus Stelara(® *) (ustekinumab) in psoriasis
[1],[2]. The updated label also includes use of Cosentyx to treat moderate-to-
severe scalp psoriasis[1] - one of the most difficult-to-treat forms of
psoriasis[3], which affects approximately 60 million people worldwide[4],[5].
The updated label is based on the proven efficacy and consistent safety profile
of Cosentyx[1].
The addition of the CLEAR study data in the European product label reflects the
benefit of Cosentyx for people living with this chronic and often distressing
condition[3]. The 52 week data show that Cosentyx is superior to Stelara in
delivering long-lasting clear or almost clear skin over one year of treatment in
adults with moderate-to-severe psoriasis[2]. Cosentyx remained consistently
superior to Stelara in achieving and sustaining a PASI 90 response (76% versus
61%) and significantly better in achieving a PASI 100 (clear skin) response (46%
versus 36%) at Week 52[2].
The updated label for Cosentyx on scalp psoriasis, in a difficult-to-treat area
of the body[3], addresses an important unmet need. Many patients with scalp
psoriasis do not achieve an adequate response from currently available
treatments[6]. Also, scalp psoriasis can be particularly challenging to treat as
disease activity is often maintained through hair care, scratching, and
shampooing of the scalp, adding to the fact that the application of topical
treatments is challenging[3]. Approximately half of all 125 million patients
with psoriasis worldwide suffer from scalp psoriasis[4],[5].
"We are happy to see these two important label updates for our IL-17A-inhibitor,
Cosentyx, the first IL-17A inhibitor approved to treat psoriasis. We are
continually investigating new areas for Cosentyx to significantly enhance
patients' quality of life, such as scalp psoriasis," said Vas Narasimhan, Global
Head, Drug Development and Chief Medical Officer, Novartis. "Cosentyx is an
innovative, groundbreaking treatment for people living with auto-inflammatory
diseases, and we're proud to continuously expand treatment possibilities for an
even greater number of patients."
Cosentyx is currently the only fully human IL-17A inhibitor to demonstrate
efficacy and safety in a dedicated Phase III study of scalp psoriasis. The CHMP
approval is based on results from the 24 week study of moderate-to-severe scalp
psoriasis where Cosentyx demonstrated superior efficacy compared to placebo[7].
Psoriasis Scalp Severity Index (PSSI) 90 responses were achieved by a
significantly greater percentage of patients receiving Cosentyx 300 mg (53%)
than placebo (2%) at Week 12 (P<0.001)[7].
The label update is applicable to all European Union and European Economic Area
countries. Cosentyx is approved in more than 75 countries for the treatment of
moderate-to-severe plaque psoriasis. Cosentyx is also approved in more than 70
countries for the treatment of active PsA and AS.
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 psoriasiss[5]. The
disease has a significant impact on patients' quality of life, which is an
aspect of the disease underestimated by most physicians[3].
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[8]. PsA is a condition 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 Cosentyx and 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, PsA and AS[10],[11].
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[1]. 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)[12].
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[1].
About the CLEAR study[2]
CLEAR (Comparison to assess Long-term Efficacy, sAfety and toleRability of
secukinumab versus ustekinumab) is a multi-center, double-blind, parallel-group
study of Cosentyx (n=335 versus Stelara (n=336) 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 1, 2 and 3, then every four weeks from Week 4, or Stelara
(dosing per package label). Cosentyx achieved the primary objective of superior
PASI 90 response at Week 16. The 52 week PASI 90 response is a secondary
objective in this study. PASI 100 and PROs responses (including DLQI) at 52
weeks are exploratory endpoints.
About the SCALP study[7]
This study is a randomized, double-blind, placebo-controlled study to evaluate
the efficacy and safety of Cosentyx in 102 patients with moderate-to-severe
scalp psoriasis. Eligible patients were equally randomized to either
subcutaneous Cosentyx 300 mg or placebo at Weeks 0, 1, 2 and 3, then every four
weeks for 12 weeks. At Week 12, patients in the placebo group who did not
achieve at least a 90% improvement from baseline in the Psoriasis Scalp Severity
Index (PSSI) score were re-randomized to Cosentyx 300 mg until study completion.
The primary endpoint was the proportion of patients who achieved PSSI 90
response rate at Week 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 labelling 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 labelling 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 (at)Novartis at
http://twitter.com/novartis
For Novartis multimedia content, please visit www.novartis.com/news/media-
library
For questions about the site or required registration, please contact
media.relations(at)novartis.com
* Stelara is a registered trademark of Janssen Biotech, Inc.
References
[1] Novartis, data on file.
[2] 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.
[3] Wozel G. Psoriasis treatment in difficult locations: scalp, nails, and
intertriginous areas. Clinics in Dermatology. 2008;26:448-459.
[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] Mason J et al. Topical preparations for the treatment of psoriasis: a
systematic review. British Journal of Dermatology. 2002;146:351-64.
[7] Bagel J et al. Secukinumab is Efficacious in Clearing Moderate-to-Severe
Scalp Psoriasis: 12 Week Results of a Randomized Phase IIIb Study. Publication.
Presented as an abstract at the 25th European Academy of Dermatology and
Venerology. Vienna, Austria. 1st October 2016.
[8] National Psoriasis Foundation. Psoriatic disease: about psoriasis. Available
at: www.psoriasis.org/about-psoriasis. Last accessed June 2017.
[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 in Pharmacological Sciences. 2009; 30(2):95-103.
[12]Cosentyx (secukinumab) [prescribing information]. East Hanover, NJ: Novartis
Pharmaceuticals Corp, 2016.
# # #
Novartis Media Relations
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E-mail: media.relations(at)novartis.com
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Novartis Global Media Relations Novartis Global Pharma Communications
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Media release (PDF):
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Source: Novartis International AG via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 06.07.2017 - 08:52 Uhr
Sprache: Deutsch
News-ID 551248
Anzahl Zeichen: 16089
contact information:
Town:
Basel
Kategorie:
Business News
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