CDSCO Panel Approves Sanofi's Protocol Amendment Proposal for SAR443122
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has approved the protocol amendment proposal presented by the drug major Sanofi to study SAR443122.
This came after the firm presented protocol amendment 2, version 1, dated 28-09-2022 before the committee.
SAR443122 is a novel, potent, and selective RIPK1 inhibitor for oral administration. SAR443122 selectively inhibits the kinase function of RIPK1 and results in the inhibition of the production of pro-inflammatory cytokines and necroptotic cell death that are thought to be detrimental to the intestinal cell integrity.
SAR443122 may become a novel treatment option for UC patients by suppressing pro-inflammatory cytokine production and inflammatory forms of cell death and therefore re-establish conditions that will lead to healing and maintaining the cell integrity of the intestine.
At the recent SEC meeting for Gastroenterology and Hepatology held on 14th June 2023, the expert panel reviewed the proposal for the protocol amendment of the RIPK1 inhibitor of the SAR443122.
After detailed deliberation, the committee recommended approval of protocol amendment 2, version 1, dated 28-09-2022 as presented by the firm
