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

• 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 treatmen^3,4
• Achieving clear skin is the ultimate treatment goal for patients with psoriasis; 50% of psoriasis patients are not content with current therapies^5-8

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 India^2.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 life^1,9.

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 spondylitis^10,11.

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 spondylitis^12-16 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 damage^18,19. 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

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