Novartis launches Scapho® Secukinumab first IL-17A inhibitor to receive approval in India for psoriasis​ treatment

Novartis launches Scapho® Secukinumab first IL-17A inhibitor to receive approval in India for psoriasis​ treatment
Highlights

Novartis Healthcare Private Limited (NHPL) announced the launch of Scapho® (secukinumab)150 mg, for the treatment of moderate-to-severe plaque psoriasis in adult patients.

  • Secukinumab is the first recombinant fully human monoclonal antibody selective for interleukin-17A1
  • Scapho® (secukinumab) has been approved by the Drug Controller General of India (DCGI) for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy2
  • In Phase III studies, 70% or moresecukinumab 300 mg patients achieved clear skin (PASI 100) or almost clear skin (PASI 90) during the first 16 weeks of treatmen3,4
  • Achieving clear skin is the ultimate treatment goal for patients with psoriasis; 50% of psoriasis patients are not content with current therapies5-8

India: Novartis Healthcare Private Limited (NHPL) announced the launch of Scapho® (secukinumab)150 mg, for the treatment of moderate-to-severe plaque psoriasis in adult patients.

Scapho® is an injectable medicine and the first interleukin-17A (IL-17A) inhibitor to be approved in India2.This approval marks a significant milestone in the treatment of psoriasis, providing a new and important first-line biologic treatment option for patients who are candidates for systemic therapy.

Secukinumab was developed for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy with a recommended dose of 300 mg. Secukinumab has demonstrated a statistically significant improvement in clearing psoriatic lesions as early as 3 weeks2.

“This is groundbreaking news as clear skin can now be a reality for patients struggling to cope with psoriasis,” said Dr. Anchala Parthasaradhi, Director - Anchala Skin Institute – Hyderabad. “Most psoriasis patients are not content with current therapy options including the earlier biologics and there is a significant unmet need. Secukinumab seems to be a promising treatment for psoriasis and can provide patients a better chance of achieving clear or almost clear skin. Importantly this therapy comes as an alternative to treatments that have significant side effects.”

“At Novartis, our mission to discover new ways to improve and extend people’s lives underscores our values and we are very happy to launch Scapho® in India for the treatment of moderate to severe psoriasis,” said Jawed Zia, Country President, Novartis India. “This signifies an important turning point in the treatment of psoriasis in India. Patients in India, can now benefit from this treatment as it has the proven ability to offer clear or almost clear skin.”

The key treatment goal for psoriasis patients is achieving clear skin. In clinical studies, 70% or more patients on secukinumab 300 mg achieved clear skin (PASI 100) or almost clear skin (PASI 90), during the first 16 weeks of treatment and importantly, this was maintained with continued treatment in the majority of patients up to Week 523. Data from the Scapho® clinical trial program also showed a significant positive relationship between achieving clear to almost clear skin and psoriasis patients’ health-related quality of life1,9.

About Secukinumab

Secukinumab is a fully human monoclonal antibody that selectively neutralizes circulating IL-17A. Research suggests that IL-17A may play an important role in driving the body’s immune response in psoriasis, psoriatic arthritis and ankylosing spondylitis10,11.

Secukinumab is approved in over 50 countries for the treatment of moderate-to-severe plaque psoriasis which includes the European Union countries, Japan, Switzerland, Australia, the US and Canada. In Europe, Secukinumab is the only biologic approved for the first-line systemic treatment of moderate-to-severe plaque psoriasis in adult patients. In the US, Secukinumab is approved as a treatment for moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy (light therapy).

In addition, Secukinumabis the first IL-17A inhibitor with positive Phase III results for the treatment of active psoriatic arthritis and active ankylosing spondylitis12-16 and is now approved in Europe, the US, Ecuador, Bangladesh and the Philippines for these conditions.Secukinumabis also approved for the treatment of psoriatic arthritis and pustular psoriasis in Japan.

About NHPL’s Dermatology portfolio

NHPL is committed to addressing the needs of patients with skin diseases and improving their quality of life by providing innovative medicines. NHPL’s dermatology portfolio includes Xolair® (Omalizumab) for Chronic Spontaneous Urticaria (CSU) and Scapho® (secukinumab) for moderate to severe psoriasis. Both these products are now available in India to meet the unmet needs of patients with skin diseases.

About psoriasis

Psoriasis is a common, non-contagious, autoimmune disease that affects up to 3% of the world’s population17. 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. 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 psoriatic arthritis, in which the joints are also affected, causing debilitating symptoms including pain, stiffness and irreversible joint damage18,19. Psoriasis is also associated with other serious health conditions, such as diabetes, heart disease and depression18.

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 and cost-saving generic pharmaceuticals. Novartis is the only global company with leading positions in these areas. In 2015, the Group achieved net sales of USD 49.4 billion, while R&D throughout the Group amounted to approximately USD 8.9 billion (USD 8.7 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 119,000 full-time-equivalent associates. Novartis productsare available in more than 180 countries around the world. For more information, please visit http://www.novartis.com

References

  1. Scapho®-India package insert dated 22 July 15 based on IPL dated 22 Oct, 13.
  2. Secukinumab DCGI approval letter F.No.4-290/Novartis/14-BD dated 18 June, 2015
  3. Langley RG, Elewski BE, Lebwohl M, et al. Secukinumab in plaque psoriasis: results of two phase three trials. New Engl J Med. 2014. Jul 9; 371(4): 326-38.
  4. Thaci D, Blauvelt A, Reich K, et al.Secukinumab is superior to ustekinumab in clearing skin of subjects with moderate to severe plaque psoriasis: CLEAR, a randomized controlled trial. J Am AcadDermatol. 2015 Sep; 73(3): 400-9.
  5. 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.
  6. 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 EurAcadDermatolVenereol
    . 2006; 20: 921-925.
  7. 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.
  8. 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.
  9. McLeod LD, Mallya UG, Fox T, Strober BE. Psoriasis Patients With PASI 90 Response Achieve Greater Health-Related Quality-of-Life Improvements Than Those With PASI 75 Response. European Association of Dermatology and Venereology, Amsterdam, Netherlands, 2014. Poster 1681.
  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 Pharmacol Sci. 2009; 30(2):95-103.
  12. Baeten D et al. Secukinumab, interleukin-17A inhibition in ankylosing spondylitis. N Engl J Med. 2015; 373:2534-48.
  13. Mease, PJ et al. Secukinumab, a human anti-interleukin-17A monoclonal antibody, in patients with psoriatic arthritis (FUTURE 2): a randomised, double-blind, placebo-controlled, phase 3 trial. The Lancet. 2015; 386(9999):1137-1146.
  14. Mease PJ et al. Secukinumab inhibition of interleukin-17A in patients with psoriatic arthritis. N Engl J Med. 2015; 373(14):1329-39.
  15. Cosentyx (secukinumab) [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp, 2016.
  16. Cosentyx Summary of Product Characteristics. Novartis Europharm Limited. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/003729/human_med_001832.jsp&mid=WC0b01ac058001d124
    . Accessed February 2016.
  17. International Federation of Psoriasis Associations (IFPA) World Psoriasis Day website. “About Psoriasis.” Available at: http://www.worldpsoriasisday.com/web/page.aspx?refid=114. Accessed February 2016.
  18. National Psoriasis Foundation. Psoriatic disease: about psoriasis. Available at: www.psoriasis.org/about-psoriasis. Accessed January 2016.
  19. 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.
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