• Feature

    1. Cosentyx Approval in the EU

      John Hohneker, MD, Global Development Franchise Head, Immunology & Dermatology, Novartis, discusses the approval of Cosentyx as a first-line treatment for moderate-to-severe plaque psoriasis in the EU

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      Photo:

      Psoriasis Infographic

      See below for PDF version

    3. NoImage
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      IL-17A Infographic

      See below for PDF version

  • Media

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      A Psoriasis Patient at Baseline

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      Psoriasis Patient Achieves PASI 75

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      Psoriasis Patient Achieves PASI 90

  • Related Documents

    1. Backgrounder: Psoriasis

    2. Backgrounder: IL-17A in Psoriasis

    3. Psoriasis Infographic

    4. IL-17A Infographic

  • Novartis Cosentyx™ is the first IL-17 inhibitor to receive EU approval for first-line treatment of moderate-to-severe psoriasis patients

  • ·  Cosentyx is the only biologic that can be used as first-line systemic therapy in the treatment of psoriasis and as an alternative to treatments that have significant side effects1; all other biologics are recommended for second-line therapy2-4

    ·  Cosentyx showed superiority to Stelara® in the Phase IIIb CLEAR study5

    ·  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 treatment6

    ·  Achieving clear skin is the ultimate treatment goal for patients with psoriasis; 50% of psoriasis patients are not content with current therapies7-10

    Basel, 19 January 2015 Novartis announced today that the European Commission (EC) has approved Cosentyx™ (secukinumab, formerly known as AIN457) as a first-line systemic* treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy.

    Cosentyx (at a dose of 300 mg) is the first and only interleukin-17A (IL-17A) inhibitor to be approved in Europe and this approval marks a significant milestone in the treatment of psoriasis, providing a new and important first-line biologic treatment option for patients. Currently, all biologic treatments for psoriasis, including anti-tumor necrosis factor therapies (anti-TNFs) and Stelara®** (ustekinumab) are recommended for second-line systemic therapy in Europe2-4.

    “With this groundbreaking news from the European Commission, clear skin may now be a reality for patients living with psoriasis,” said David Epstein, Division Head, Novartis Pharmaceuticals. “Nearly half of psoriasis patients are not content with current therapies, including biologic treatments, showing a significant unmet need for patients. Cosentyx, with a first-line systemic indication for treatment of psoriasis will provide patients a better chance of achieving clear or almost clear skin.”

    The key treatment goal for psoriasis patients is achieving clear skin. In clinical 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 and importantly, this was maintained with continued treatment in the majority of patients up to Week 526. Data from the Cosentyx clinical trial program also showed a significant positive relationship between achieving clear to almost clear skin and psoriasis patients’ health-related quality of life11.

    The EU approval follows the recent results of the Phase IIIb CLEAR study, which showed that Cosentyx was superior to Stelara®** in clearing skin of patients living with moderate-to-severe plaque psoriasis. The CLEAR study was the second head-to-head study for Cosentyx. Cosentyx also showed superiority to Enbrel®*** (etanercept) in clearing skin in the FIXTURE study6. In the Phase III clinical program the overall safety profile of Cosentyx was favorable, with minimal differences seen between etanercept and ustekinumab in head-to-head comparison5,6.

    In addition to the EU, Cosentyx has been approved in Australia for the treatment of moderate-to-severe plaque psoriasis and in Japan for the treatment of moderate-to-severe plaque psoriasis and active psoriatic arthritis (PsA).

    The US Food and Drug Administration (FDA) decision in moderate-to-severe plaque psoriasis is anticipated early in 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 (secukinumab) and interleukin-17A (IL-17A)
    Cosentyx is a human monoclonal antibody that selectively neutralizes IL-17A12,13. IL-17A is found in high concentrations in skin affected by psoriasis and is a preferred target for investigational therapies12-17. Cosentyx works by inhibiting the action of interleukin-17A (IL-17A), a protein found in high concentrations in skin affected by the disease12-17. In the Phase III program, Cosentyx demonstrated a favorable safety profile, with similar incidence and severity of adverse events between secukinumab treatment arms (300 mg and 150 mg)5,18-20.

    Phase IIIb studies in psoriasis are ongoing in palmo-plantar psoriasis, nail psoriasis and palmo-plantar pustulosis.

    Cosentyx is also in Phase III development for psoriatic arthritis (PsA) and ankylosing spondylitis (AS); regulatory applications are planned for 2015.

    About Psoriasis
    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 life7,21,22. Psoriasis affects up to 3% of the world’s population, or more than 125 million people23. In Europe, the estimate is about 0.8%, which means that plaque psoriasis affects about 3.7 million Europeans, with about 2.4 million considered to have moderate-to-severe disease24.

    This common and distressing condition is not simply a cosmetic problem – even people with very mild symptoms are affected everyday7. Furthermore, there is an urgent need for new psoriasis treatments, as up to 50% of patients are not content with current therapies, including biologic treatments7-10.
     

  • Full Press Release

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 135,000 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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