Sponsor should submit rescue management plan: CDSCO Panel Tells Sun Pharma Over Psoriasis Drug Tildrakizumab
New Delhi: Granting the permission to conduct the proposed study of Tildrakizumab 100mg/ml, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has opined the drug major Sun Pharma that the sponsor should submit rescue management plan and provide effective standard of care treatment free of cost to non-responding trial subjects till 52 weeks of study period.
This came in line with the Phase II/III clinical trial protocol no. TILD-19-12 amendment No. 2.0 dated 21.11.2022 presented by the drug major Sun Pharma.
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.
Earlier the Medical Dialogues Team had reported that in response to the drug major Sun Pharma's 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) had recommended the firm to conduct a Phase III bridging clinical trial with at least 100 patients, which should include 5% patients of psoriasis with tuberculosis.
In continuation, at the recent SEC meeting for Dermatology and Allergy held on 12.01.2023, the expert panel reviewed the Phase II/III clinical trial protocol no. TILD-19-12 amendment No. 2.0 dated 21.11.2022 presented by drug major Sun Pharma regarding the Tildrakizumab 100mg/ml for the treatment of severe plaque psoriasis.
The committee noted that the drug is approved in US and EU countries in adult with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
After detailed deliberation, the committee recommended the grant of permission to conduct the proposed study with condition that the sponsor should submit rescue management plan and provide effective standard of care treatment free of cost to non-responding trial subjects till 52 weeks of study period.
