Conduct Phase III bridging CT: CDSCO Panel tells Sun Pharma over psoriasis drug Tildrakizumab
New Delhi: Denying the request to import and market monoclonal antibody Tildrakizumab Injection 100 mg/ml with a local clinical trial waiver, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has recommended to drug major Sun Pharma that the firm should conduct a Phase III bridging clinical trial with at least 100 patients, which should include 5% patients of psoriasis with tuberculosis.
This came after the drug maker presented their proposal for import and marketing of the drug with a local clinical trial waiver.
Earlier, the Medical Dialogues Team had reported that, 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) had opined the firm to 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.
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.
At the recent SEC meeting for Dermatology and Allergy held on 18th August 2022,the expert panel reviewed the proposal of Tildrakizumab Injection 100mg/ml for the treatment of severe plaque psoriasis, presented by drug major Sun Pharma.
It was noted that the proposal of the firm was earlier deliberated on August 12, 2021, for import and marketing with a local clinical trial waiver, wherein the committee recommended that the firm should submit safety and efficacy data of the drug in Indian population for further consideration.
Accordingly, the proposal for Phase III clinical trial was deliberated on 15.03.2022 wherein 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 proposed trial design for further review by the committee.
Further, the firm, in their letter dated May 3, 2022, requested to withdraw the CT application and to consider again their proposal for import and marketing permission with a local clinical trial waiver for SEC deliberation.
Accordingly, the firm presented their proposal for import and marketing of the drug with a local clinical trial waiver.
Finally, after detailed deliberation, the committee recommended that the firm should conduct a Phase III bridging clinical trial with at least 100 patients, which should include 5% patients of psoriasis with tuberculosis.
