Pfizer's Abrocitinib Phase III Data Accepted by CDSCO Expert Committee
New Delhi: The Subject Expert Committee (SEC) under the Dermatology and Allergy division of the Central Drugs Standard Control Organisation (CDSCO) has reviewed and considered the Phase III clinical trial data submitted by Pfizer Products India Private Limited for its drug Abrocitinib Tablets in 100 mg and 200 mg strengths.
The review was conducted during the 6th meeting of the SEC (Dermatology & Allergy) held on 11th June 2025 at CDSCO Headquarters, New Delhi. The company’s submission was presented in reference to the earlier SEC recommendation dated 15th February 2022.
As per the 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.”
After detailed deliberation, the committee considered the Phase III clinical trial result of Abrocitinib 100 mg and 200 mg Tablets as presented by the firm.
Abrocitinib is a selective Janus kinase 1 (JAK1) inhibitor indicated for the treatment of moderate-to-severe atopic dermatitis in patients who are candidates for systemic therapy. The purpose of the Phase III trial was to evaluate the safety and efficacy of the drug in the target population.
Pfizer Products India Private Limited, the Indian subsidiary of Pfizer Inc., submitted the trial data to CDSCO as part of the regulatory process under the New Drugs Division. The results included clinical outcomes for both dosage strengths.
The committee’s latest recommendation did not specify any objections, queries, or additional conditions, suggesting that the Phase III data was accepted as presented.
