Hetero Biopharma gets CDSCO panel nod to market, manufacture Tenecteplase
New Delhi: Pharma major Hetero Biopharma has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drugs Standard Control Organization (CDSCO) to manufacture and market Tenecteplase 30 mg, 40 mg, and 50 mg in Vial, indicated for "thrombolytic treatment of suspected myocardial infarction with persistent ST elevation."
However, this approval is conditional on Hetero Biopharma conducting a Phase IV clinical trial with 400 subjects.
This came after the drug maker Hetero Biopharma presented the proposal to manufacture and market the drug Tenecteplase (30 mg, 40 mg, and 50 mg) in vials for the indication "thrombolytic treatment of suspected myocardial infarction with persistent ST elevation" along with the results of the Phase III local clinical trial.
Tenecteplase is a modified form of recombinant human tissue plasminogen activator used in the emergency treatment of myocardial infarction and pulmonary emboli.
Tenecteplase binds to fibrin rich clots via the fibronectin finger-like domain and the Kringle 2 domain. The protease domain then 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. This helps eliminate blood clots or arterial blockages that cause myocardial infarction.
At the recent SEC meeting for Cardiovascular and Renal, dated December 21,2022, the expert panel reviewed the proposal presented by drug major Hetero Biopharma to manufacture and market the drug Tenecteplase 30 mg, 40 mg, and 50 mg in vials for the indication "thrombolytic treatment of suspected myocardial infarction with persistent ST elevation" along with the results of the Phase III local clinical trial.
Regarding the above, the expert panel noted the results of the Phase III clinical trial.
After detailed deliberation, the committee recommended the grant of permission for the manufacturing and marketing of the drug, subject to the condition that the firm conduct a Phase IV clinical trial in 400 subjects.
Accordingly, the committee directed the firm to submit the Phase IV clinical trial protocol within 3 months of marketing approval.
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