Submit Phase II CT safety data: CDSCO panel tells Pfizer over Ritlecitinib
New Delhi: Denying the proposal presented by the pharma major Pfizer for Phase III CT of the drug Ritlecitinib, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has recommended the firm to submit the complete Phase II clinical trial safety data to CDSCO for the further evaluation.
This came after the firm presented its proposal for Phase III clinical trial with protocol number B7981040 dated 28 July 2022 before the committee.
Ritlecitinib is an investigational oral once-daily treatment that is the first in a new class of oral highly selective kinase inhibitors that is a dual inhibitor of the TEC family of tyrosine kinases and of Janus kinase 3 (JAK3).
After detailed deliberation, the committee recommended that the firm should submit the complete Phase II clinical trial safety data to CDSCO for review by the committee for taking further action on the proposed Phase III clinical trial Protocol.
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