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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...
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.
Also Read:MSN Lab gets CDSCO Panel nod for phase III CT of Elagolix Tablets
Doctor of Pharmacy
Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.