Submit the PSUR data: CDSCO Tells Hetero Biopharma on Phase IV CT protocol of Tenecteplase Lyophilized powder for injection
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has granted approval to the drug major Hetero Biopharma to conduct the Phase IV study of the Tenecteplase 30mg/6ml, 40mg/8ml, & 50mg/10ml; Lyophilized powder for injection in vial with condition to submit the Periodic safety update reports (PSUR) data of patients on the drug every six months for further review by CDSCO.
This came after the firm presented the Phase IV study protocol titled “A Phase IV, post-marketing, prospective, multicentre, single-arm clinical study to evaluate the safety, efficacy and immunogenicity of Hetero- Tenecteplase for thrombolysis in acute myocardial infarction” vide protocol HCR/IV/TENESTEMI/02/2023 version 1.0 dated 06.02.2023 along with a request to change the Phase IV study sample size condition stipulated in New Drug permission dated 01.02.2023 for manufacture and market Tenecteplase 30 mg/6 ml, 40 mg/8 ml, 50 mg/10 ml Lyophilized powder for injection in the vial (rDNA origin) to 200 evaluable patients instead of 400 patients.
Tenecteplase is a bioengineered alteplase variant, a recombinant DNA-derived version of naturally occurring tissue plasminogen activator (tPA). The drug is derived from three amino acid substitutions at three sites (T, N, and K represent the three regions changed from the natural tPA protein).
Tenecteplase is a thrombolytic (THROM-bo-LIT-ik) drug, sometimes called a "clot-busting" drug. It helps your body produce a substance that dissolves unwanted blood clots. Tenecteplase is used to prevent death in people who have had a heart attack (acute myocardial infarction)
Tenecteplase binds to fibrin-rich clots and cleaves the Arg/Val bond in plasminogen to form plasmin. Plasmin in turn degrades the fibrin matrix of the thrombus, thereby exerting its thrombolytic action.
At the recent SEC meeting for Cardiovascular and Renal held on the 6th and 7th of July 2023, the expert panel reviewed the protocol titled “A Phase IV, post-marketing, prospective, multicentre, single-arm clinical study to evaluate the safety, efficacy and immunogenicity of Hetero- Tenecteplase for thrombolysis in acute myocardial infarction” vide protocol HCR/IV/TENESTEMI/02/2023 version 1.0.
After detailed deliberation, the committee recommended the grant of permission to conduct the Phase IV study as per protocol presented by the firm with the condition to submit the PSUR data of patients on the drug every six months for further review by CDSCO.
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