Study Safety and Efficacy of Tenecteplase 0.25 mg/kg in Acute Ischemic Stroke: CDSCO Panel Tells Boehringer Ingelheim
New Delhi: Rejecting the drug major Boehringer Ingelheim's request for waiver of the local clinical trial of Metalyse 25 mg (tenecteplase 0.25 mg/kg) for the additional indication, acute ischemic stroke (AIS), the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the firm to conduct a phase III study in Indian patients to establish the safety and efficacy of the drug for AIS indication with the proposed dose of 0.25mg/kg.
This came after Boehringer Ingelheim India presented the proposal for approval of additional indications for the drug Metalyse 25 mg (tenecteplase 0.25 mg/kg) lyophilized powder for solution for injection based on the clinical data generated from the global clinical studies conducted for Acute Ischemic Stroke (AIS) with the request of local clinical trial waiver.
The committee noted that a dose of 0.2mg/kg for the drug is approved in India for AIS indication for another manufacturer. However, the firm has proposed a higher dose i.e. 0.25mg/kg for the drug which is not approved in India.
Tenecteplase is a modified form of recombinant human tissue plasminogen activator used in the emergency treatment of myocardial infarction and pulmonary emboli. Tenecteplase is an FDA-approved medication specifically indicated for reducing mortality in patients with ST-elevation acute myocardial infarction (STEMI). Off-label indications include thrombolysis in treating acute ischemic stroke, pulmonary embolism, and central venous catheter clearance.
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.
At the recent SEC meeting for neurology and psychiatry held on the 18th and 19th of January 2024, the expert panel reviewed the proposal for approval of additional indications for the drug Metalyse 25 mg (tenecteplase 0.25 mg/kg) lyophilized powder for solution for injection.
After detailed deliberation, the committee did not consider the firm’s request for waiver of the local clinical trial and recommended the firm conduct a Phase III study in Indian patients to establish the safety and efficacy of the drug for acute ischemic stroke (AIS) indication with the proposed dose of 0.25mg/kg.
