Sun Pharmaceutical Gets CDSCO Panel Nod To import, market plaque psoriasis drug Tildrakizumab injection

New Delhi: Pharmaceutical major Sun Pharmaceutical has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to manufacture and market Tildrakizumab injection 100 mg/ml for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

However, this nod came with the condition that the firm should conduct the post-marketing surveillance (PMS) study. The PMS study protocol should also include safety parameters for cardiac evaluation and for baseline and post-treatment screening of tuberculosis.

This followed after the firm presented the proposal for grant of permission to import and market Tildrakizumab injection 100 mg/mL based on the clinical study results of a Phase III clinical trial conducted in India to assess the efficacy, safety, and immunogenicity of the drug in Indian patients with moderate to severe plaque psoriasis.

Tildrakizumab-asmn injection is in a class of medications called monoclonal antibodies. Tildrakizumab is a humanized IgG1/k monoclonal antibody that selectively binds to the p19 subunit of the interleukin-23 (IL-23) cytokine and inhibits its interaction with the IL-23 receptor. IL-23 plays a critical role in modulating inflammatory and immune responses.

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 has been found to be a promising treatment approach in patients with moderate-to-severe chronic plaque psoriasis. Upon administration, downregulation of Th17 and Th22 cell responses occurs.

At the recent SEC meeting for Dermatology and Allergy held on 11th February 2025, the expert panel reviewed the proposal for grant of permission to import and market Tildrakizumab injection 100 mg/ml based on the clinical study results of a Phase III clinical trial conducted in India to assess the efficacy, safety, and immunogenicity of the drug in Indian patients with moderate to severe plaque psoriasis.

After detailed deliberation, the committee recommended the grant of permission to import and market Tildrakizumab injection 100 mg/mL for the indication "Indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy,” with the condition to conduct a post-marketing surveillance study.

In addition, the expert panel stated that the PMS study protocol should also include safety parameters for cardiac evaluation and for baseline and post-treatment screening of tuberculosis.

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