Intas Pharma unveils DCGI-approved drug for Atopic Dermatitis treatment

June 30, 2023 | Friday | News

Atopic Dermatitis is a chronic relapsing condition leading to poor quality of life and psychosocial complications

Ahmedabad-based Intas Pharmaceuticals has launched TOFATAS – a Drugs Controller General of India (DCGI)-approved, Tofacitinib Ointment 2% w/w for the treatment of mild to moderate Atopic Dermatitis (AD) in patients 18 years and above having flare-ups of the disease.

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. 

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.

"There have been no approved Topical JAK inhibitors in India available to date and 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.

Dr Alok Chaturvedi (Associate Executive Vice President & Head-Medical Affairs, Intas) said "A Phase III clinical study of TOFATAS (Tofacitinib Ointment 2% w/w) in Atopic Dermatitis patients in India showed remarkable safety and efficacy."

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