CDSCO penal asked for more data on Tildrakizumab

This came after the firm presented the clinical trial protocol for the Phase III clinical trial of Tildrakizumab before the committee.

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CDSCO Panel Expert Committee
CDSCO Panel Expert Committee

New Delhi: In response to the drug-major Sun Pharma’s phase 3 protocol for immunomodulator Tildrakizumab, the Subject Expert Committee (SEC) functional under the Central Drugs Standard Control Organization (CDSCO) has opined the firm to present more data on unmet medical need for the drug in the country.

In addition to this, the firm is told to provide a rationale for the proposed trial design for further review by the committee.

This came after the firm presented the clinical trial protocol for the Phase III clinical trial of Tildrakizumab before the committee.

Tildrakizumab is a humanized, high-affinity IgG1- antibody that targets interleukin 23 p19 and has shown promise in the evolution of treatment strategies for chronic plaque psoriasis.

Plaque psoriasis is a chronic autoimmune disease that appears on the skin as red, raised areas of the skin covered with flaky white scales that can crack and bleed.

Tildrakizumab is a monoclonal antibody designed for the treatment of immunologically mediated inflammatory disorders. Tildrakizumab was designed to block interleukin-23 (IL-23), a cytokine that plays a key role in managing the immune system and autoimmune diseases.

This drug selectively binds to the interleukin (IL)-23 p19 subunit of the cytokine IL-23 and neutralises 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.

Last year, the Medical Dialogues Team had reported that Sun Pharma Canada Inc., a wholly owned subsidiary of Sun Pharmaceuticals Industries Limited, had launched PrILUMYA (tildrakizumab injection) to treat adults living with moderate to-severe plaque psoriasis in Canada.

At the recent SEC meeting for Dermatology and Allergy, the expert panel extensively reviewed the clinical trial protocol for the Phase III clinical trial of Tildrakizumab presented by the pharmaceutical major Sun Pharma.

After detailed deliberation, the committee recommended that the firm should present more data on unmet medical need for the drug in the country along with the rationale for the proposed trial design for further review by the committee.

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