Novartis Healthcare gets DCGI nod to market Scapho for first-line treatment of moderate-to-severe psoriasis
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. The clearance by the Drugs Controller General of India (DCGI) provides a new and important first-line biologic treatment option for patients who are candidates for systemic therapy.
Secukinumab treats adult patients with a recommended dose of 300 mg. The drug has demonstrated a statistically significant improvement in clearing psoriatic lesions as early as 3 weeks.
“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, said Dr. Anchala Parthasaradhi, director - Anchala Skin Institute – Hyderabad.
“Our mission to discover new ways to improve people’s lives. The launch of Scapho in India signifies an important turning point in the treatment of psoriasis in India,” said Jawed Zia, country president, Novartis India.
The key treatment goal for psoriasis patients is achieving clear skin. In clinical studies, 70 per cent 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 this was maintained with continued treatment in the majority of patients up to week 52. Data from the Scapho clinical trial programme also showed a significant positive relationship between achieving clear to almost clear skin and psoriasis patients’ health-related quality of life.
Secukinumab is a fully human monoclonal antibody that selectively neutralises 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. The drug is approved in over 50 countries for the treatment of moderate-to-severe plaque psoriasis which includes the European Union, 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.