Conduct Active Surveillance Study: CDSCO Panel Tells Pfizer on Abrocitinib tablets
New Delhi: In line with the drug major Pfizer Products proposal to waive the specific condition mentioned in the import and marketing permission of Abrocitinib tablets 50 mg, 100 mg, and 200 mg to conduct a Phase IV clinical trial, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has opined that the firm should conduct the active surveillance study.
This came after the firm presented a proposal before the committee for grant of waiver to condition no. 8 mentioned in the import and marketing permission of Abrocitinib tablets 50 mg, 100 mg, and 200 mg to conduct of Phase IV clinical trial.
The committee noted the recommendations of the SEC dated 14.06.2023, for the subject drug. At the earlier SEC meeting dated 14.06.2023, the committee recommended the grant of import permission for the sale or for distribution of Abrocitinib tablets 50mg, 100mg, and 200mg indicated for the treatment of adults with refractory, moderate-to-severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when the use of those therapies is inadvisable subject to the following conditions:
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.
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