- Cosentyx (secukinumab) approval is based on Phase III program demonstrating high, sustained efficacy in the skin clearance of moderate-to-severe plaque psoriasis and improvement of signs and symptoms of psoriatic arthritis[1-5]
- Many patients do not respond to or tolerate current psoriasis or psoriatic arthritis treatments, indicating an unmet need for new therapies for these diseases[6-11]
- Psoriatic arthritis affects 30% of psoriasis patients globally and can cause irreversible joint damage[12],[13], with this approval, these patients now have a new treatment option that effectively treats both diseases
- In Phase III studies, 70% or more Cosentyx 300 mg patients achieved clear skin (PASI 100) or almost clear skin (PASI 90) during the first 16 weeks of treatment[1]
Basel, December 26, 2014 - Novartis announced today that the Japanese Ministry of Health, Labour and Welfare (MHLW) approved Cosentyx(TM) (secukinumab, formerly known as AIN457), for the treatment of both psoriasis vulgaris and psoriatic arthritis (PsA) in adults who are not adequately responding to systemic* therapies (except for biologics). This approval marks the first country approval for Cosentyx in the world and makes it the first interleukin-17A (IL-17A) inhibitor to receive regulatory approval in either of these indications in Japan.
Cosentyx works by inhibiting the action of IL-17A, a protein that is found in high concentrations in skin affected by psoriasis and central to the development of inflammatory diseases, including psoriasis and PsA[14-19]. As approximately 30% of psoriasis patients are also affected by PsA globally[12], this approval means that these patients in Japan now have a new treatment option that effectively treats both diseases.
"We are pleased that Japan is the first country to approve Cosentyx for both psoriasis and psoriatic arthritis, providing an alternative treatment option for more than 400,000 Japanese citizens who are living with psoriasis, and those also living with psoriatic arthritis," said David Epstein, Division Head, Novartis Pharmaceuticals. "Nearly half of patients with psoriasis and PsA are unhappy with their current therapies. With this approval, we are able to address this critical unmet need and aim to make a real difference in the quality of life of these patients."
In psoriasis clinical trials, 70% of patients achieved clear or almost clear skin within the first 16 weeks of treatment with Cosentyx 300 mg (p<0.0001), which was maintained in the majority of patients up to Week 52 (with continued treatment)[1]. In the PsA trials, Cosentyx demonstrated significant and sustained efficacy versus placebo in improving signs and symptoms of PsA, as measured by a 20% reduction in the American College of Rheumatology response criteria (ACR 20), which is a standard criteria to assess the effectiveness of arthritis treatments. Between 50% to 54% of Cosentyx patients achieved at least ACR 20 in two pivotal studies, FUTURE 1 (150 mg; p<0.0001) and FUTURE 2 (150 and 300 mg; p<0.0001)[4],[5].
Psoriasis is a chronic immune-mediated disease characterized by thick and extensive skin lesions, called plaques, known to cause itching, scaling and pain; it is associated with significant impairment of physical and psychological quality of life[6],[20],[21]. Closely linked with psoriasis, PsA causes joint pain and stiffness, skin and nail psoriasis, swollen toes and fingers, persistent painful tendonitis and irreversible joint damage[13]. Up to 40% of people can suffer from joint destruction and permanent physical deformity[22].
This approval was based on the safety and efficacy results from more than 10 Phase II and Phase III studies which included nearly 4,000 patients with moderate-to-severe plaque psoriasis[1-3],[13] and supported by two pivotal Phase III studies, FUTURE 1 and FUTURE 2, involving more than 1,000 patients with PsA[4],[5]. In all studies, Cosentyx demonstrated a favorable safety profile, with similar incidence and severity of adverse events (AEs) between Cosentyx treatment arms (300 mg and 150 mg)[1-5],[23].
The positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommending Cosentyx as a first-line treatment of moderate-to-severe psoriasis patients in Europe was obtained in November 2014. US Food and Drug Administration (FDA) approval in the same indication is anticipated in early 2015 following the unanimous recommendation of approval in October 2014 from the Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) to the US FDA.
About Cosentyx(TM) (secukinumab) and interleukin-17A (IL-17A)
Cosentyx is a human monoclonal antibody that selectively neutralizes IL-17A[14],[15]. IL-17A is found in high concentrations in skin affected by psoriasis and is a preferred target for investigational therapies[14],[19]. Research also shows that IL-17A plays an important role in driving the body's immune response in other inflammatory arthritic diseases, including psoriatic arthritis and ankylosing spondylitis[26].
Phase III development for psoriatic arthritis and ankylosing spondylitis is also underway; global regulatory applications for Cosentyx in these arthritic conditions are planned for 2015.
About Psoriasis
Psoriasis affects up to 3% of the world's population, or more than 125 million people[25]. In Japan, it is estimated that up to 430,000 people are affected by psoriasis[27].
This common and distressing condition is not simply a cosmetic problem - even people with very mild symptoms are affected everyday[6]. Furthermore, there is an urgent need for new psoriasis treatments, as up to 50% of patients are not content with current therapies, including biologic treatments[6-9].
About Psoriatic Arthritis (PsA)
Psoriatic arthritis (PsA) is a debilitating, long-lasting inflammatory disease linked with significant disability, poor quality of life and reduced life expectancy[12]. Between 0.3% and 1% of the general population may be affected by PsA and as many as one in four people with psoriasis may have undiagnosed PsA[12],[24]. PsA impacts over 3% of psoriasis patients in Japan[28].
Disclaimer
The foregoing release contains forward-looking statements that can be identified by words such as "aim," "positive opinion," "anticipated," "recommendation," "underway," "planned," or similar terms, or by express or implied discussions regarding potential marketing authorizations for Cosentyx, or regarding potential future revenues from Cosentyx. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management 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 Cosentyx will be submitted for sale in any additional markets, or approved for any indication, or at any particular time. Nor can there be any guarantee that Cosentyx will be commercially successful in the future. In particular, management's expectations regarding Cosentyx could be affected by, among other things, the uncertainties inherent in research and development, including unexpected clinical trial results and additional analysis of existing clinical data; unexpected regulatory actions or delays or government regulation generally; the company's ability to obtain or maintain proprietary intellectual property protection; general economic and industry conditions; global trends toward health care cost containment, including ongoing pricing pressures; unexpected 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, eye care, cost-saving generic pharmaceuticals, preventive vaccines, over-the-counter and animal health products. Novartis is the only global company with leading positions in these areas. In 2013, the Group achieved net sales of USD 57.9 billion, while R&D throughout the Group amounted to approximately USD 9.9 billion (USD 9.6 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 133,000 full-time-equivalent associates and sell products in more than 150 countries around the world. For more information, please visit http://www.novartis.com.
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*Systemic: treatments or medication absorbed into the blood stream, allowing them to be carried where they are needed to work
References
[1] Langley RG, Elewski BE, Lebwohl M, et al. Secukinumab in plaque psoriasis: results of two phase three trials. N Engl J Med. 2014. Jul 9;371(4):326-38.
[2] Blauvelt A, Prinz J, Gottlieb AB, et al. Secukinumab Administration by Pre-filled Syringe: Efficacy, Safety, and Usability Results from a Randomized Controlled Trial in Psoriasis (FEATURE). Br J Dermatol. 2014; [published online ahead of print August 16, 2014].
[3] Paul C, Lacour JP, Tedremets L, et al. Efficacy, safety, and usability of secukinumab administration by autoinjector/pen in psoriasis: a randomized, controlled trial (JUNCTURE). J Eur Acad Dermatol Venereol. 2014; [published online ahead of print September 22, 2014].
[4] Mease PJ, McInnes IB, Kirkham B, et al. Secukinumab, a human anti-interleukin-17A monoclonal antibody, improves active psoriatic arthritis and inhibits radiographic progression: efficacy and safety data from a phase 3 randomized, multicenter, double-blind, placebo-controlled study. Oral presentation at: ACR/ARHP Annual Meeting, Boston, MA, USA, 2014. Presentation number 948.
[5] McInnes IB. Secukinumab, a Human Anti-Interleukin-17A Monoclonal Antibody, Improves Active Psoriatic Arthritis: 24-Week Efficacy and Safety Data from a Phase 3 Randomized, Multicenter, Double-Blind, Placebo-Controlled Study Using Subcutaneous Dosing. Oral presentation at: ACR/ARHP Annual Meeting, Boston, MA, USA, 2014. Abstract number: L1.
[6] Stern RS, Nijsten T, Feldman S, et al. Psoriasis Is Common, Carries a Substantial Burden Even When Not Extensive, and Is Associated with Widespread Treatment Dissatisfaction. J Investig Dermatol Symp. 2004;9(2):136-9.Nestle FO, Kaplan DH, Barker J. Psoriasis. N Engl J Med. 2009; 361(5):496-509.
[7] Christophers E, Griffiths CEM, Gaitanis G, et al. The unmet treatment need for moderate to severe psoriasis: results of a survey and chart review. J Eur Acad Dermatol Venereol. 2006;20:921-925.
[8] Krueger JG, Koo J, Lebwohl M, et al. The impact of psoriasis on quality of life: Results for a 1998 National Psoriasis Foundation patient membership survey. Arch Derm. 2001;137:280-284.
[9] Sterry W, Barker J, Boehncke WH, et al. Biological therapies in the systemic management of psoriasis: International Consensus Conference. Br J Dermatol. 2004;151 Suppl 69:3-17
[10] Dougados M, Baeten D. Spondyloarthritis. Lancet. 2011; 377:2127-37.
[11] Armstrong A, Robertson A, Wu J, et al. Undertreatment, Treatment Trends, and Treatment Dissatisfaction Among Patients With Psoriasis and Psoriatic Arthritis in the United States: Findings From the National Psoriasis Foundation Surveys, 2003-2011.JAMA Dermatol. 2013; 149(10):1180-1185.
[12] Gladman DD, Antoni C, Mease P, et al. Psoriatic arthritis: epidemiology, clinical features, course, and outcome. Ann Rheum Dis. 2005; 64:ii14-ii17.
[13] American College of Rheumatology (ACR) website. "Spondylarthritis (Spondylarthropathy)."http://www.rheumatology.org/Practice/Clinical/Patients/Diseases_And_Conditions/Spondylarthritis_(Spondylarthropathy)/. Accessed December 2013.
[14] Gaffen SL. Structure and signaling in the IL-17 receptor family. Nat Rev Immunol. 2009;9(8):556-67.
[15] Ivanov S, Linden A. Interleukin-17 as a drug target in human disease. Trends Pharmacol Sci. 2009;30(2):95-103.
[16] Kopf M, Bachmann MF, Marsland BJ. Averting inflammation by targeting the cytokine environment. Nat Rev Drug Discov. 2010; 9(9):703-18.
[17] Onishi RM, Gaffen SL. Interleukin-17 and its target genes: mechanisms of interleukin-17 function in disease. Immunology. 2010;129(3):311-21.
[18] 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.
[19] Johansen C, Usher PA, Kjellerup RB, et al. Characterization of the interleukin-17 isoforms and receptors in lesional psoriatic skin. Brit J Dermatol. 2009;160(2):319-24.
[20] Rapp SR, Feldman SR, Exum ML, Fleischer AB, Jr., Reboussin DM. Psoriasis causes as much disability as other major medical diseases. J Am Acad Dermatol. 1999; 41(3 Pt 1):401-7.
[21] Farley E et al. Psoriasis: comorbidities and associations. G Ital Dermatol Venereol. 2011 Feb;146(1):9-15.
[22] Medscape Reference website. "Medical Care in Psoriatic Arthritis." http://emedicine.medscape.com/article/331037-overview#a30. Accessed October 2014.
[23] Novartis data on file. 2013: Clinical study reports for CAIN457A2302 [ERASURE] ; CAIN457A2303 [FIXTURE] ; CAIN457A2307 [JUNCTURE] ; CAIN457A2308 [FEATURE].
[24] Van Baarsen LGM, Lebre MC, van der Coelen D, et al. IL-17 levels in synovium of patients with rheumatoid arthritis, psoriatic arthritis and osteoarthritis: Target validation in various forms of arthritis. Ann Rheum Dis. 2011;70:A79.
[25] International Federation of Psoriasis Associations (IFPA) World Psoriasis Day website. "About Psoriasis." http://www.worldpsoriasisday.com/web/page.aspx?refid=114. Accessed February 2014.
[26] Mease PJ, Armstrong AW. Managing patients with psoriatic disease: the diagnosis and pharmacologic treatment of psoriatic arthritis in patients with psoriasis. Drugs. 2014;74:423-41.
[27] Kubota K, Sato M, Ohaba N, et al. National Reciept database no Katsuyo Kanosei wo saguru - Kansen no Ekigaku Kenkyu Kara- (Potential usage of National Receipt database - epidemiology study of psoriasis -). Japanese Society of Pharmacoepidemiology, November 16-17, 2013, Tokyo, 2013:39
[28] Takahashi H, Nakamura K, Kaneko F, et, al. Analysis of psoriasis patients registered with the Japanese Society for Psoriasis Research from 2002-2008. Journal of Dermatology. 2011;38: 1125-1129.
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