Conduct Active Surveillance Study: CDSCO Panel Tells Pfizer on Abrocitinib tablets

1) The firm should conduct a Phase IV clinical trial for which the firm should submit a Phase IV clinical trial protocol within 3 months of approval of the drug for review by the committee.

2) The firm should submit periodic safety update reports (PSURs) as per the Rules.

Abrocitinib is a kinase inhibitor used to treat moderate-to-severe atopic dermatitis in adults. Abrocitinib is used to treat moderate to severe eczema (atopic dermatitis; a skin disease that causes the skin to be dry and itchy and to sometimes develop red, scaly rashes) in adults and children 12 years of age and older who cannot use other medications for their condition or whose eczema has not responded to other.

At the recent SEC meeting for Dermatology and Allergy held on 5th September 2024, the expert panel reviewed a proposal for a grant of a waiver to the condition mentioned in the import and marketing permission of Abrocitinib tablets 50 mg, 100 mg, and 200 mg to conduct of Phase IV clinical trial.

After detailed deliberation, the committee opined that the firm should conduct an active surveillance study.

Accordingly, the expert panel suggested that the firm should submit the study protocol along with parameters for further review by the committee and further consideration of Phase IV clinical trial waiver.

Also Read: Submit safety data on South Asian subjects with Plaque Psoriasis: CDSCO Panel Tells Johnson & Johnson on Ustekinumab