Generate Phase II Clinical Data on 20 Indian subjects for dose selection: CDSCO panel Tells Pfizer on Ritlecitinib
New Delhi: Noting that in the presented Phase II clinical trial data, no Indian subjects were involved and the study disease is very heterogeneous, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the drug major Pfizer to generate the Phase II clinical data of the Ritlecitinib on 20 Indian subjects for dose selection of proposed IMP (Investigational Medicinal Products).
This came after the drug major Pfizer presented the justification and proposal for the grant of Phase III Clinical Trial permission Protocol No.:B7981040 dated 28 July 2022 before the committee.
Ritlecitinib is a kinase inhibitor used to treat severe alopecia areata (an autoimmune disorder that causes patchy hair loss) in adults and adolescents 12 years and older. This medicine is a Janus kinase 3 (JAK3) and tyrosine kinase inhibitor that works on the immune system.
At the recent SEC meeting for Dermatology and Allergy held on 17th August 2023, the expert panel reviewed the justification and proposal presented by Pfizer for the grant of Phase III Clinical Trial permission of Ritlecitinib.
After detailed deliberation, the committee again recommended that the firm should generate the Phase II clinical data on 20 Indian subjects for dose selection of proposed IMP as in the presented Phase II clinical trial data, no Indian issues were involved and the study disease is very heterogeneous.
In accordance with the above, the expert panel suggested that the clinical trial protocol should be submitted for review and the data generated in Phase II data should be presented before the SEC for further consideration to grant permission to conduct the proposed Phase III clinical trial.
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