Sun Pharma gets CDSCO Panel nod to study Tildrakuzimab
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has given its nod to study the efficacy and safety of tildrakizumab compared to placebo in anti-TNF naïve subjects with active psoriatic arthritis II.
This came after the drug major Sun Pharma presented justification along with the Phase III clinical trial of the monoclonal antibody Tildrakuzimab protocol no. TILD19-19 amendment 1.1 (India Specific) dated 04/07/2022 (Inspire 2) before the committee.
Psoriatic arthritis (PsA) is a chronic inflammatory joint disease which develops in patients with psoriasis. It is characteristic that the rheumatoid factor in serum is absent. Etiology of the disease is still unclear but a number of genetic associations have been identified.
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 disease.
Tildrakuzimab is a targeted immunomodulator that decreases inflammation by inhibiting the action of various cytokines associated with plaque psoriasis, thus relieving its symptom of scaly plaques
At the recent SEC meeting for Analgesic & Rheumatology held on 14th December 2022, the expert panel reviewed the justification and the Phase III clinical trial of the monoclonal antibody protocol no. TILD19-19 amendment 1.1 (India Specific) dated 04/07/2022 (Inspire 2).
The committee noted that as per the proposed protocol, Methotrexate/Leflunomide /SoC is already mentioned in the protocol and is to be provided in the placebo arm as well as the treatment arm throughout the treatment during the conduct of the trial.
Furthermore, the expert panel noted that the drug major Sun Pharma agreed that the Data and Safety Monitoring Board (DSMB) recommendation to be submitted to CDSCO and more Govt. sites to be included in the study.
After detailed deliberation, the committee recommended the grant of permission to conduct the study of the monoclonal antibody Tildrakuzimab.
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