Delving into the Latest Updates on Streptokinase biosimilar(Sanofi Healthcare India Pvt Ltd.) with Synapse

Overview

Basic Info

Drug Type

Biosimilar, Enzyme

Synonyms

Shankinase

Target

PLG

Mechanism

PLG stimulants(Plasminogen stimulants)

Therapeutic Areas

Cardiovascular Diseases

Active Indication

Myocardial Infarction

Inactive Indication-

Originator Organization

Sanofi Healthcare India Pvt Ltd.

Active Organization

Sanofi Healthcare India Pvt Ltd.

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

IN (01 Jan 2004),

Myocardial Infarction

Regulation-

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BACKGROUNDStreptokinase is the most widely used thrombolytic agent and can now be made using recombinant DNA technology. The present trial was initiated to assess an indigenous recombinant streptokinase (Shankinase, r-SK).AIMTo compare the efficacy and safety of indigenous recombinant streptokinase (Shankinase, r-SK) and natural streptokinase (Streptase, n-SK).SETTINGS AND DESIGNDouble blind, randomized, non-inferiority, multicentric, parallel study.MATERIALS AND METHODSPatients of AMI < 6 hours of chest pain and 2 mm ST elevation in 2 contiguous chest leads V(1)-V(6) or 1 mm in limb leads were randomized to receive 1.5 miu of either r-SK or n-SK. CK Peaking and decrease of > or = 50% ST segment were used to assess reperfusion.STATISTICAL ANALYSISDifference in the groups was assessed by chi-square or paired t test as required. Probability value < 0.05 was considered significant with 95% confidence interval.RESULTSOverall 150 patients were recruited (96 r-SK group and 54 in n-SK group) and demographic and clinical profile of the groups was comparable. Reperfusion was seen in 68.2% (58) and 69.4% (34) patients in r-SK and n-SK groups respectively. Commonly seen adverse events were fever in 7 (8.5%), hypotension in 3 (3.6%), nausea in 2 (2.4%) patients. Minor bleeding were seen in 4 (4.8%) of patients.CONCLUSIONIndigenous recombinant Streptokinase (r-SK) is as efficacious as natural streptokinase (n-SK) in establishing reperfusion as assessed by non-invasive parameters with comparable side effect profile.

100 Deals associated with Streptokinase biosimilar(Sanofi Healthcare India Pvt Ltd.)

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