Intas Pharma Gets Expert Panel Nod For PMS Data On Tofacitinib Ointment In Atopic Dermatitis
New Delhi: Intas Pharma has received approval from the Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) for the results of its Post-Marketing Surveillance (PMS) study on Tofacitinib 2% w/w ointment in adult patients with mild to moderate atopic dermatitis, including those experiencing flare-ups.
The update was discussed during the SEC’s 7th meeting held on 23rd July 2025 at the CDSCO headquarters in New Delhi. The firm presented the report of an active PMS study, which was conducted to assess the real-world effectiveness and safety of the topical Janus kinase (JAK) inhibitor formulation.
The PMS study focused on adult patients diagnosed with mild to moderate atopic dermatitis, particularly those suffering from flare-ups of the condition. The firm submitted its findings before the committee for evaluation, which included real-world data collected under post-marketing conditions.
After a comprehensive review and detailed deliberation, the committee acknowledged the results submitted by the company and recommended acceptance of the data presented in the PMS study.
Tofacitinib, a JAK inhibitor, is more commonly used in oral form for autoimmune conditions. However, its topical formulation for dermatological use in atopic dermatitis represents a growing area of interest in India, especially for patients seeking localized and non-systemic treatment options.
The committee’s acceptance of the PMS study results reflects regulatory confidence in the product's post-marketing safety and real-world efficacy in the Indian population. This could pave the way for broader clinical adoption of Tofacitinib 2% ointment as a therapeutic option in dermatology.
“After detailed deliberation, the committee recommended to accept the results of active PMS study presented by the firm.”
