Sun Pharma Gets CDSCO Panel Nod to Study Tildrakizumab Injection 100 mg/ ml
New Delhi: The drug major Sun Pharma has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the clinical trial of Tildrakizumab injection, a monoclonal antibody designed for the treatment of immunologically mediated inflammatory disorders.
This came after the drug major Sun Pharma presented phase 3 clinical study protocol no. TILD-21.01, amendment 2 dated 9th November 2023.
Tildrakizumab is a high-affinity, humanized, IgG1 κ antibody targeting interleukin 23 p19 that shows promise in the evolution of treatment strategy in chronic plaque psoriasis.
This drug selectively binds interleukin (IL)-23 p19 subunit of cytokine IL-23 and neutralizes its function IL-23 regulates Th17 cells and is a powerful activator of keratinocyte proliferation. Targeting IL-23p19 alone is a promising treatment approach in patients with moderate-to-severe chronic plaque psoriasis. Upon administration, downregulation of Th17 and Th22 cell responses occurs.
IL-23 is a naturally occurring cytokine that is involved in inflammatory and immune responses. Tildrakizumab inhibits the release of proinflammatory cytokines and chemokines.
At the recent SEC meeting for Analgesic and Rheumatology held on the 6th of February 2024, the expert panel reviewed the Phase III clinical study of the drug Tildtildrakizumab injection.
After detailed deliberation, the committee recommended a grant of permission to conduct the trial as presented by the firm.
