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Intas Pharmaceuticals Ltd on Thursday announced the launch of TOFATAS - a tofacitinib ointment 2 per cent% w/w for the treatment of mild to moderate Atopic Dermatitis (AD) in patients 18 years and above having flare-ups of the disease.
The ointment is approved by the regulator - Drug Controller General of India (DCGI).
Dr Alok Chaturvedi, Associate Executive Vice President & Head-Medical Affairs, Intas, said, “Intas being a frontrunner in dermatology therapy, boldly and successfully endeavoured to bridge this critical treatment gap by investing in extensive research efforts to develop and formulate TOFATAS Ointment. A Phase III clinical study of TOFATAS (Tofacitinib Ointment 2% w/w) in Atopic Dermatitis patients in India showed remarkable safety and efficacy.”
Atopic Dermatitis (AD) is a chronic inflammatory, non-communicable, and relapsing skin disease that most often develops in all age groups. It is a multifactorial disease arising from a complex interaction between genetic, environmental, and immunological factors.
The quality of life of the patients suffering from AD is compromised due to factors like consistent itching, sleep disturbances, poor performance at school/work, and disturbed social, mental, and emotional functioning.
Despite the unmet needs, approximately 15 years have passed since a topical therapy with a new mechanism of action for AD has been introduced in India, a statement from Intas said.
“There have been no approved Topical JAK inhibitors in India available to date. The approval of TOFATAS Ointment 2%, therefore, would help in patients who desire a steroid-free topical agent for Atopic Dermatitis, and we hope that real-world data mirrors the approvals given to this agent in India,” said Dr Kabir Sardana, Professor (Dermatology) at the RML Hospital, Delhi.
“AD is a chronic relapsing condition leading to poor quality of life and psychosocial complications. Current therapy has unmet needs. We welcome the DCGI- approved new topical Tofacitinib 2%, which will give new hope to these sufferers,” said Dr Satish Udare, Senior Consultant Dermatologist, Thane/Navi Mumbai.
Safety issues with existing therapies - Topical Corticosteroids / Topical Calcineurin Inhibitors - in the management of AD have always been a challenge in the long run as they are accompanied by increased risks of side effects which impact the patient’s quality of life. Furthermore, due to the distinct characteristics of AD, its management remains a challenge.
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