CDSCO Panel Grants Eli Lilly's Protocol Amendment Proposal of Baricitinib Study
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has approved the protocol amendment proposal presented by drug major Eli-Lilly for Baricitinib, a Janus kinase inhibitor.
This came after the drug major Eli-Lilly presented their proposal for protocol amendment vide protocol No. I4V-MC-JAIP(c)dated 14 Feb 2023 before the committee.
Baricitinib is in a class of medications called Janus kinase (JAK) inhibitors. It works by decreasing the activity of the immune system.
Baricitinib is an orally available, selective Janus kinase (JAK) inhibitor with potency and selectivity for JAK1 and JAK2 and less potency for JAK3 or tyrosine kinase 2 (TYK2).
Atopic dermatitis (AD) is a pruritic, chronic, or chronically relapsing, highly symptomatic inflammatory skin disease characterized by excessive T cell activation leading to significant skin infiltration by T cells and dendritic cells.
The pathogenesis of AD is thought to be modulated through thymic stromal lymphopoietin (TSLP), interleukin (IL)-13, IL-4, IL-5, IL-22, and IL-31, many of which activate receptors with downstream signaling through intracellular JAK1/JAK2/TYK2. This activity profile suggests that baricitinib would inhibit cytokines involved in AD pathogenesis.
At the recent SEC meeting for Dermatology and Allergy held on the 13th of September 2023, the expert panel reviewed the proposal for protocol amendment of Baricitinib study vide protocol No. I4V-MC-JAIP(c) dated 14 Feb 2023, presented by drug major Eli-Lilly.
After detailed deliberation, the committee recommended approval of the proposed amendment as presented by the firm.
Also Read:AstraZeneca gets CDSCO Panel Nod to study asthma drug Benralizumab
