Pfizer Gets CDSCO Panel nod to Import Abrocitinib tablets for moderate to severe atopic dermatitis
New Delhi: Pharmaceutical major Pfizer Products India has got the go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to import Abrocitinib tablets 50 mg, 100 mg, and 200 mg for sale or for distribution for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy.
However, this nod is subject to the condition that the firm should conduct a Phase IV clinical trial study.
This came after Pfizer Products India presented its application for grant of permission to import Abrocitinib tablets 50mg, 100mg, and 200mg for sale or for distribution along with Phase III clinical study data to the committee.
The committee noted that the proposed additional indication of Abrocitinib tablets 50 mg, 100 mg, and 200 mg is approved in the USA, Europe, and other countries.
Abrocitinib is an oral small-molecule inhibitor of Janus kinase 1 (JAK1). Janus kinases are intracellular enzymes involved in transduction pathways that regulate hematopoiesis and immune cell function. The Janus kinase (JAK)-signal transducer and activator of transcription (STAT) signalling pathway plays a central role in the pathogenesis of a variety of autoimmune and inflammatory diseases, including atopic dermatitis, a chronic inflammatory skin disease with complex pathogenesis. Atopic dermatitis is characterized by epidermal hyperplasia, skin barrier dysfunction, and the aberrant activation of immune cells.
At the recent SEC meeting for dermatology and allergy held on 5th and 6th December 2024, the expert panel reviewed the application presented by Phizer Product India to import Abrocitinib tablets 50mg, 100mg, and 200mg for sale or distribution along with Phase III clinical study data.
After detailed deliberation, the committee recommended the grant of import permission for the sale or distribution of Abrocitinib tablets 50 mg, 100 mg, and 200 mg indicated for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy, subject to the condition that the firm should conduct a Phase IV clinical trial study.
Accordingly, the expert panel suggested that the firm should submit the Phase IV clinical trial protocol to CDSCO within 3 months from the date of approval of the drug product for review by the committee.
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