GlobeNewswire

Novartis Cosentyx® gains positive CHMP opinion for pediatric psoriasis, reinforcing established efficacy and safety profile

Share
  • EMA CHMP positive opinion paves way for Cosentyx® to become a first-line systemic treatment in pediatric psoriasis
  • CHMP opinion based on two Phase III studies showing Cosentyx provides fast and strong skin clearance and significant improvement in quality of life1
  • Moderate-to-severe psoriasis affects more than 350,000 children worldwide2, with the physical and psychological burden disrupting important formative years3
  • Potential new indication reinforces Cosentyx leadership in immuno-dermatology and rheumatology and follows recent EU approval in non-radiographic axial spondyloarthritis (nr-axSpA), with plans to expand to 10 indications over the next 10 years

Basel, June 26, 2020 — Novartis, a leader in immuno-dermatology and rheumatology, today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for Cosentyx® (secukinumab) for the treatment of moderate-to-severe plaque psoriasis in children and adolescents aged 6 to <18 years.

“Psoriasis affects children much deeper than just the skin and can lead to deterioration of quality of life, potentially having a lasting impact on this vulnerable patient population,” said Todd Fox, Global Head of Medical Affairs Immunology, Hepatology and Dermatology at Novartis. “This is our second positive CHMP opinion for Cosentyx this year alone, following on from recent EC approval in nr-axSpA. The latest positive opinion is an important step forward in our commitment to reimagining care for children with psoriasis, giving them freedom to enjoy full and active lives.”

The positive CHMP opinion is based on two Phase III international studies in children and adolescents aged 6 to <18 years, one open‑label, two-arm, parallel‑group, multicentre study with moderate-to-severe plaque psoriasis and one randomized, double-blind, placebo and etanercept-controlled study with severe plaque psoriasis. The studies showed both low-dose (75–150 mg) and high-dose (75–300 mg) of Cosentyx were highly efficacious in rapidly improving skin symptoms and quality of life, with a favorable safety profile up to 52 weeks.

In children with moderate-to-severe plaque psoriasis, the low dose of Cosentyx provided fast and strong skin clearance, with 93% achieving Psoriasis Area Severity Index (PASI) 75 as early as Week 12, 69% achieving PASI 90 at Week 12 and 88% at Week 24, 59.5%% achieving completely clear skin (PASI 100) by Week 12 and 67% by Week 24. In patients with severe psoriasis, the low dose of Cosentyx ensured sustained skin clearance through Week 52, with PASI 90 achieved in 75% of patients1. Differences in PASI 75 in patients with severe psoriasis treated with Cosentyx were seen as early as Week 4 and in patients with moderate-to-severe psoriasis as early as Week 2.

Half of children with moderate-to-severe plaque psoriasis treated with low dose of Cosentyx reported complete relief from symptom burden of psoriasis on their quality of life by as early as Week 12, as measured by Children's Dermatology Life Quality Index (CDLQI) 0/1 responses. In children with severe plaque psoriasis treated with low dose of Cosentyx, 44.7% reported complete relief by Week 12, with 60.6% by Week 52. Cosentyx safety profile of both the low dose and high dose is comparable and consistent with the established adult psoriasis indication. No new safety signals were observed in children.

Phase III data in moderate-to-severe plaque psoriasis were presented as a late breaking abstract at the 2020 American Academy of Dermatology Virtual Meeting Experience (AAD VMX) in June 20204

About psoriasis
Psoriasis is a life-long debilitating systemic inflammatory disease that significantly impacts patients’ quality of life, both physically and emotionally5. One-third of psoriasis cases begin in childhood and of these the onset is most common during adolescence6. Moderate-to-severe psoriasis affects more than 350,000 children worldwide and may impact children “deeper than the skin”, with the physical and psychological burden of psoriasis disrupting important formative years2. The incidence of pediatric psoriasis has more than doubled between 1970 and 2000 in the US and an upward trend in incidence of psoriasis has been observed in several countries5,6. There are only a few approved treatment options available and the unmet medical need remains high3.

About Cosentyx (secukinumab)
Cosentyx is the first and only fully-human biologic that directly inhibits interleukin-17A (IL-17A), an important cytokine involved in the inflammation and development of psoriatic arthritis (PsA), moderate-to-severe plaque psoriasis (PsO), ankylosing spondylitis (AS) and nr-axSpA7,8,9.

Cosentyx is backed by robust clinical evidence, including five-year data across three indications of PsO, PsA and AS, as well as data from real world evidence10-15. These data strengthen the unique position of Cosentyx as a rapid and long-lasting comprehensive treatment across axSpA, PsA and psoriatic disease, with more than 340,000 patients treated worldwide with Cosentyx since launch16-18.

Disclaimer
This press release contains 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,” “may,” “could,” “would,” “expect,” “anticipate,” “seek,” “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; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, 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 is reimagining medicine to improve and extend people’s lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world’s top companies investing in research and development. Novartis products reach nearly 800 million people globally and we are finding innovative ways to expand access to our latest treatments. About 109,000 people of more than 145 nationalities work at Novartis around the world. Find out more at
https://www.novartis.com.

Novartis is on Twitter. Sign up to follow @Novartis at https://twitter.com/novartisnews
For Novartis multimedia content, please visit https://www.novartis.com/news/media-library
For questions about the site or required registration, please contact media.relations@novartis.com

References

  1. Novartis data on file.
  2. Parisi R, Symmons DP, Griffiths CE, et al. Identification and Management of Psoriasis and Associated ComorbidiTy (IMPACT) project team. Global epidemiology of psoriasis: a systematic review of incidence and prevalence. J Invest Dermatol. 2013;133(2):377‐385.
  3. Menter A, Cordoro KM, Davis DMR, et al. Joint American Academy of Dermatology–National Psoriasis Foundation guidelines of care for the management and treatment of psoriasis in pediatric patients. J Am Acad Dermatol. 2020;82:161-201.
  4. Magnolo N, Kingo K, Laquer V, at al. Secukinumab is Highly Efficacious and Has a Favorable Safety Profile in Pediatric Patients with Moderate-to-Severe Plaque Psoriasis. Late-breaking abstract presented at the virtual American Academy of Dermatology Annual Meeting. Mar 20–24, 2020.
  5. World Health Organization. Global report on psoriasis [online] 2016. Available from: https://apps.who.int/iris/handle/10665/204417 [Last accessed: June 2020].
  6. Tollefson MM, Crowson CS, McEvoy MT, et al. Incidence of psoriasis in children: a population-based study. J Am Acad Dermatol. 2010;62(6):979-87.
  7. Girolomoni G, Mrowietz U, Paul C, et al. Psoriasis: rationale for targeting interleukin-17. Br J Dermatol. 2012;167:717-24.
  8. Sieper J, Poddubnyy D, Miossec P. The IL-23–IL-17 pathway as a therapeutic target in axial spondyloarthritis. Nat Rev Rheumatol. 2019;15:747-57.
  9. Jansen DT, Hameetman M, van Bergen J, et al. IL-17-producing CD4+ T cells are increased in early, active axial spondyloarthritis including patients without imaging abnormalities. Rheumatology (Oxford). 2015;54(4):728-735.
  10. Data on file. CAIN457F2310 (MEASURE 2): 5 Year Report. Novartis Pharmaceuticals Corp; September 15, 2015.
  11. Data on file. Data Analysis Report: Study CAIN457A2302E1. Novartis Pharmaceuticals Corp; November 30, 2015.
  12. Marzo-Ortega H, Sieper J, Kivitz A. 5-year efficacy and safety of secukinumab in patients with ankylosing spondylitis: end-of-study results from the phase 3 MEASURE 2 trial. Lancet Rheumatol 2020;2: e339–46.
  13. Data on file. CAIN457F2312 Data Analysis Report. Novartis Pharmaceuticals Corp; November 2008.
  14. Data on file. CAIN457F2310 (MEASURE 1 and 2): Pooled Safety Data. Novartis Pharmaceuticals Corp; July 23, 2018.
  15. Data on file. COSENTYX Access. Novartis Pharmaceuticals Corp; May 2019.
  16. Data on file. AIN457A2102 Clinical Study Report. Novartis Pharmaceuticals Corp; December 2008.
  17. Data on file. COSENTYX Access. Novartis Pharmaceuticals Corp; June 2020.

# # #

Novartis Media Relations
E-mail: media.relations@novartis.com

Antonio Ligi
Novartis Global External Communications
+41 61 324 1374 (direct)
antonio.ligi@novartis.com



Eric Althoff
Novartis US External Communications
+1 646 438 4335
eric.althoff@novartis.com
Louise Clark
Novartis Pharma Communications
+41 61 324 2970 (direct)
louise.clark@novartis.com

Novartis Investor Relations
Central investor relations line: +41 61 324 7944
E-mail: investor.relations@novartis.com

CentralNorth America
Samir Shah+41 61 324 7944Sloan Simpson+1 862 778 5052
Thomas Hungerbuehler 
Isabella Zinck
+41 61 324 8425
+41 61 324 7188

About GlobeNewswire

GlobeNewswire
GlobeNewswire
One Liberty Plaza - 165 Broadway
NY 10006 New York

https://globenewswire.com

GlobeNewswire is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.

Subscribe to releases from GlobeNewswire

Subscribe to all the latest releases from GlobeNewswire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from GlobeNewswire

Scandinavian Tobacco Group A/S udsteder EUR 300 millioner erhvervsobligationer18.9.2020 08:00:00 CESTpressemeddelelse

Selskabsmeddelelse Nr. 27/2020 København, 18. september 2020 Scandinavian Tobacco Group A/S udsteder EUR 300 millioner erhvervsobligationer Denne meddelelse og indholdet heraf må ikke udleveres, offentliggøres eller distribueres, direkte eller indirekte, i USA, Canada, Japan eller Australien eller i nogen anden jurisdiktion, hvor udlevering, offentliggørelse eller distribution ville være ulovlig.Denne meddelelse udgør ikke et tilbud om at sælge eller en opfordring til at fremsætte tilbud om at købe nogen værdipapirer i Scandinavian Tobacco Group A/S eller STG Global Finance B.V. i USA, Canada, Japan eller Australien eller nogen anden jurisdiktion. STG Global Finance B.V., et helejet datterselskab til Scandinavian Tobacco Group A/S, har gennemført prisning af en udstedelse af en 5-års usikret erhvervsobligation garanteret af Scandinavian Tobacco Group A/S med en hovedstol på EUR 300 millioner, forfald i september 2025 og en kuponrente på 1,375 %. Udstedelsen blev overtegnet lidt over to

Saniona deltar i den virtuella konferensen Oppenheimer Fall Healthcare Life Sciences & MedTech Summit 202018.9.2020 08:00:00 CESTPressemelding

PRESSMEDDELANDE 18 september 2020 Saniona (OMX: SANION), ett biofarmaceutiskt företag med klinisk utveckling fokuserad på sällsynta sjukdomar, meddelar idag att företagets koncernchef och VD Rami Levin kommer att delta i ett virtuellt ”samtal vid brasan” i samband med konferensen Oppenheimer & Co. Fall Healthcare Life Sciences & MedTech Summit som anordnas 21-23 september 2020. Närmare uppgifter om det virtuella samtalet vid brasan presenteras nedan. Oppenheimer & Co. 2020 Fall Healthcare Life Sciences & MedTech Summit Datum: Tisdag 22 september 2020 Tid: 10.50 ET Länk till webbsändning: https://wsw.com/webcast/oppenheimer5/sanion.st/3751533 Samtalet vid brasan kommer att websändas live, och kan nås via sidan ”Intervjuer och webbsändningar” på Sanionas webbplats: https://saniona.com/se/investors/interviews-webcasts/. Efter livesändningen kommer samtalet att finnas arkiverat på Sanionas webbplats i ungefär 90 dagar. För mer information, var vänlig kontakta Trista Morrison, Chief Communi

Saniona to Participate in Oppenheimer’s Virtual 2020 Fall Healthcare Life Sciences & MedTech Summit18.9.2020 08:00:00 CESTPress release

PRESS RELEASE September 18, 2020 Saniona (OMX: SANION), a clinical stage biopharmaceutical company focused on rare diseases, today announced that Rami Levin, President and Chief Executive Officer of Saniona, will participate in a virtual fire side chat at the Oppenheimer & Co. Fall Healthcare Life Sciences & MedTech Summit being held September 21–23, 2020. Details on the virtual fire side chat are shown below. Oppenheimer & Co. 2020 Fall Healthcare Life Sciences & MedTech Summit Date: Tuesday September 22, 2020 Time: 10:50 a.m. ET Webcast Link: https://wsw.com/webcast/oppenheimer5/sanion.st/3751533 A live webcast of the fire side chat will be available in the Interviews & Webcasts section of the Saniona website found here: https://saniona.com/investors/interviews-webcasts/. After the live webcast, this event will remain archived on the Saniona website for approximately 90 days. For more information, please contact Trista Morrison, Chief Communications Officer. Mobile + 1 (781) 810 9227

Scandinavian Tobacco Group A/S issues EUR 300 million Corporate Bond18.9.2020 08:00:00 CESTPress release

Company Announcement No. 27/2020 Copenhagen, 18 September 2020 Scandinavian Tobacco Group A/S issues EUR 300 million Corporate Bond The information contained herein is not a release, publication or distribution, directly or indirectly, in or into the United States, Canada, Japan or Australia or any other jurisdiction in which such release, publication or distribution would be unlawful.This announcement does not constitute an offer to sell or the solicitation of an offer to buy securities in Scandinavian Tobacco Group A/S or STG Global Finance B.V. in the United States, Canada, Japan or Australia or any other jurisdiction. STG Global Finance B.V., a wholly-owned subsidiary of Scandinavian Tobacco Group A/S, has successfully priced an issuance of a 5 year unsecured corporate bond for a principal amount of EUR 300 million with maturity in September 2025 and with a coupon of 1.375%. The issuance was more than two times oversubscribed. The bonds are guaranteed by Scandinavian Tobacco Group

Roche launches new quantitative antibody test to measure SARS-CoV-2 antibodies, to support the evaluation of vaccines18.9.2020 07:03:00 CESTPress release

The new Elecsys Anti-SARS-CoV-2 S test can quantitatively measure the level of antibodies against SARS-CoV-2 in patients who have been exposed to the virus. The test targets antibodies against the spike protein. This is the focus of vaccines in development and convalescent plasma therapy.1Using the Elecsys Anti-SARS-COV-2 S antibody test, together with the Elecsys Anti-SARS-CoV-2* test launched in May, can help to more effectively determine the percentage of a population who already have antibodies against SARS-COV-2. Basel, 18 September 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the launch of its Elecsys® Anti-SARS-CoV-2 S antibody test for markets accepting the CE Mark. Roche has filed for Emergency Use Authorisation (EUA) from the U.S. Food and Drug Administration (FDA). The Elecsys Anti-SARS-CoV-2 serology test can be used to quantitatively measure antibodies in people who have been exposed to the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and can p

IMCD acquires Finnish distributor of composite materials Kokko-Fiber18.9.2020 07:00:00 CESTPress release

ROTTERDAM, The Netherlands (18 September 2020, 07:00 CET) – IMCD N.V. (“IMCD” or the “Company”), a leading distributor of speciality chemicals and ingredients, today announces that it has acquired 100% of the share capital of Oy Kokko-Fiber Ab (“Kokko-Fiber”), a leading supplier of fiber-reinforced plastic composite materials in Finland. Kokko-Fiber, founded in 1994, serves a broad customer base that includes many of the largest Finnish companies that use fiber-reinforced plastics in their operations. The company has five employees and generated a revenue of €9.0 million in 2019. Sami Valkama, Managing Director IMCD Finland, comments: “IMCD Finland was established 25 years ago and since then we have strived to offer our customers best-in-class solutions. We recognize the importance of the composite business in the Nordic region. With this acquisition, IMCD will not only expand and strengthen its relationship with other suppliers in the composites’ market, but it will be in an excellent