India's Central Drugs Standard Control Organisation (CDSCO) expert committee has accepted Pfizer's Phase III clinical trial data for abrocitinib, marking a significant regulatory milestone for the selective Janus kinase 1 (JAK1) inhibitor in treating moderate-to-severe atopic dermatitis.
The review was conducted during the 6th meeting of the Subject Expert Committee (SEC) for Dermatology & Allergy held on June 11, 2025, at CDSCO headquarters in New Delhi. Pfizer Products India Private Limited, the Indian subsidiary of Pfizer Inc., presented comprehensive Phase III data for both 100 mg and 200 mg tablet formulations.
Regulatory Review Process
According to official meeting minutes, "In light of earlier SEC recommendation dated 15.02.2022, firm presented Phase III CT report of Abrocitinib 100 mg and 200 mg Tablets before the committee." The submission was part of the regulatory process under the New Drugs Division, building upon previous committee recommendations from February 2022.
After detailed deliberation, the committee considered the Phase III clinical trial results for both dosage strengths as presented by the firm. Notably, the committee's latest recommendation did not specify any objections, queries, or additional conditions, suggesting that the Phase III data was accepted as presented.
Drug Profile and Indication
Abrocitinib is a selective JAK1 inhibitor specifically indicated for the treatment of moderate-to-severe atopic dermatitis in patients who are candidates for systemic therapy. The Phase III trial was designed to evaluate both the safety and efficacy of the drug in this target population.
The clinical trial results included outcomes for both the 100 mg and 200 mg dosage strengths, providing comprehensive data on the drug's performance across different dosing regimens. This dual-dose approach allows for potential treatment optimization based on individual patient needs and response profiles.
Clinical Significance
The acceptance of Phase III data represents a crucial step in the regulatory pathway for abrocitinib in India's pharmaceutical market. Atopic dermatitis patients requiring systemic therapy often face limited treatment options, making the potential availability of a selective JAK1 inhibitor particularly significant for addressing unmet medical needs in dermatological care.
The committee's acceptance without additional conditions or queries suggests that the Phase III data met the regulatory standards for safety and efficacy evaluation, potentially streamlining the path toward final approval consideration.
