Present more data on unmet medical need for Tildrakizumab: CDSCO Panel tells Sun pharma
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.
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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