Submit Phase II CT safety data: CDSCO panel tells Pfizer over Ritlecitinib

Published On 2023-02-27 12:30 GMT | Update On 2023-02-27 12:30 GMT

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).

Ritlecitinib, a selective JAK3/TEC kinase inhibitor has been demonstrated to inhibit the action of signalling molecules and immune cells responsible for hair loss in people with alopecia areata.

Alopecia areata is a disease that happens when the immune system attacks hair follicles and causes hair loss. Hair follicles are the structures in the skin that form hair. While hair can be lost from any part of the body, alopecia areata usually affects the head and face.

At the recent SEC meeting for the Dermatology & Allergy held on 15th February 2023, the expert panel reviewed the proposal presented by the drug major Pfizer for conducting Phase III clinical trial of Ritlecitinib.

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

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Dr. Divya Colin

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.

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Submit Phase II CT safety data: CDSCO panel tells Pfizer over Ritlecitinib

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