Delving into the Latest Updates on Idrabiotaparinux sodium with Synapse

Overview

Basic Info

Drug Type

Chemical drugs

Synonyms

Biotinylated idraparinux, SS-126517E, SSR 126517

+ [2]

Target

factor Xa

Action

inhibitors

Mechanism

factor Xa inhibitors(Factor Xa inhibitors)

Therapeutic Areas

Nervous System DiseasesCardiovascular DiseasesRespiratory Diseases

Active Indication-

Inactive Indication

Atrial FibrillationIschemic strokePulmonary Embolism+ [2]

Originator Organization

Sanofi

Active Organization-

Inactive Organization

SanofiAventis (China) Investment Co. Ltd.Sanofi-Aventis Recherche & Développement SA

+ [1]

License Organization-

Drug Highest PhaseDiscontinuedPhase 3

First Approval Date-

Regulation-

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Structure/Sequence

Molecular FormulaC53H88N4NaO51S8

InChIKeyDARDLXOMABZMLW-OWWFDHMYSA-N

CAS Registry405159-59-3

A Multicenter, Randomized, Double-blind, Assessor-blind, Non-inferiority Study Comparing the Efficacy and Safety of Once-weekly Subcutaneous Biotinylated Idraparinux (SSR126517E) With Oral Adjusted-dose Warfarin in the Prevention of Stroke and Systemic Thromboembolic Events in Patients With Atrial Fibrillation

The objective is to evaluate whether once weekly subcutaneous (SC) injection of idrabiotaparinux sodium (biotinylated idraparinux) is at least as efficient to prevent clots in brain and in the other organs than oral international normalized ratio (INR) adjusted-dose warfarin in patients with atrial fibrillation (AF).

Start Date01 Dec 2007

Sponsor / Collaborator

Sanofi

NCT00345618

/ CompletedPhase 3

An International, Multicenter, Randomized, Double-blind, Double-dummy, Parallel Group, Study of 3-month or 6-month Treatment With SSR126517E (3.0 mg s.c. Once-weekly) Versus Oral INR-adjusted Warfarin in the Treatment of Patients With Symptomatic Pulmonary Embolism With or Without Symptomatic Deep Venous Thrombosis

Objectives are to evaluate whether idrabiotaparinux sodium (SSR126517E) is as least as effective as a standard warfarin treatment to prevent recurrence of venous thromboembolic events (VTE) in patients with symptomatic pulmonary embolism (PE) with or without symptomatic deep venous thrombosis (DVT) and to assess its safety (bleedings) versus warfarin.

Start Date01 Jun 2006

Sponsor / Collaborator

Sanofi

NCT00311090

/ CompletedPhase 3

International, Multicenter, Randomized, Parallel Group, Double-blind Study, in Patients With Acute Symptomatic Deep Vein Thrombosis of the Lower Limbs, Demonstrating the Bioequipotency at Steady State of Equimolar Doses of SSR126517E (3.0 mg) Once a Week and SR34006 (2.5 mg) Once a Week, Documenting the Safety and Efficacy of Both Compounds During a 6-month Treatment, and Demonstrating the Neutralizing Effect of SSR29261 on the SSR126517E-induced Anti-Xa Activity

The three purposes of this study are the following:
* To compare during a 6-month treatment the safety and effectiveness of idrabiotaparinux (SSR126517) with that of idraparinux (SR34006), taking into account new events of deep venous thrombosis (DVT) and pulmonary embolism (PE), and bleeding risk;
* To compare the activities of idrabiotaparinux and idraparinux directly in blood during and after a 6-month treatment;
* To check the ability of avidin (SSR29261) to reverse the blood thinning activity of idrabiotaparinux at the end of a 6-month treatment period.

Start Date01 Apr 2006

Sponsor / Collaborator

Sanofi

100 Clinical Results associated with Idrabiotaparinux sodium

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100 Translational Medicine associated with Idrabiotaparinux sodium

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100 Patents (Medical) associated with Idrabiotaparinux sodium

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29

Literatures (Medical) associated with Idrabiotaparinux sodium

01 Apr 2020·Journal of arrhythmia

Clinical outcomes associated with kidney function changes in anticoagulated atrial fibrillation patients: An ancillary analysis from the BOREALIS trial

Article

Author: Gregory Y. H. Lip ; Ying Bai ; Alena Shantsila

Abstract:

Background:

Patients with atrial fibrillation (AF) and chronic kidney disease represent a high‐risk group for thromboembolism and bleeding.

Aims:

To explore the relationship between kidney function changes and outcomes of stroke/systemic embolism (SE), major bleeding and all‐cause death in anticoagulated AF patients participating in the BOREALIS trial comparing efficacy and safety of once‐weekly s.c. idrabiotaparinux to that of warfarin.

Methods:

Changes in kidney function by estimated glomerular filtration rate (eGFR) were calculated using the Chronic Kidney Disease Epidemiology Collaboration equation in 2765 AF patients. Trial adjudicated outcomes were determined.

Results:

After a mean follow‐up of 394 days, in 94.4% of the included patients kidney function changed ranging from −30 mL/min to 30 mL/min. The incidence of stroke/SE and major bleeding was similar between patients with deteriorated (reduction in eGFR from baseline over follow‐up) and preserved kidney function change (increase or no change in eGFR from baseline over follow‐up) [stroke/SE: incidence rate (IR): 1.33%/year vs 1.80%/year; hazard ratio (HR) 0.74, 95% confidence interval (CI) 0.41‐1.32, P = .30; major bleeding: IR 1.63%/year vs 1.49%/year, HR 1.10, 95% CI 0.61‐1.97, P = .76]. On Cox regression analysis, patients with deteriorated kidney function were at higher risk for all‐cause death, compared to patients with preserved kidney function (HR: 1.64, 95% CI: 1.02‐2.63, P = .04).

Conclusion:

In the BOREALIS trial, the risk of adjudicated stroke/SE, major bleedings, and all‐cause death was not related to mild‐moderate follow‐up changes in kidney function (±30 mL/min). The risk of all‐cause death was significantly increased in AF patients with abruptly deteriorating kidney function.

01 Jun 2014·Journal of thrombosis and haemostasis : JTHQ2 · MEDICINE

Comparison of idrabiotaparinux with vitamin K antagonists for prevention of thromboembolism in patients with atrial fibrillation: the Borealis‐Atrial Fibrillation Study

Q2 · MEDICINE

Article

Author: J. Halperin ; G.J. Hankey ; G. Pillion ; M.H. Prins ; G.E. Raskob ; H.R. Buller

BACKGROUND:

Idrabiotaparinux, a long-acting inhibitor of factor Xa, was shown to be effective in the treatment of patients with venous thromboembolism.

OBJECTIVE:

To assess non-inferiority for the efficacy of idrabiotaparinux versus warfarin in patients with atrial fibrillation (AF) at risk of stroke and systemic embolism. Bleeding was also assessed.

METHODS:

This randomized, double-blind trial enrolled patients with electrocardiogram-documented AF. Idrabiotaparinux was administered weekly via subcutaneous injection, and warfarin was administered daily with dose adjustment to maintain the international normalized ratio between 2.0 and 3.0. Each idrabiotaparinux injection was 3 mg for the first 7 weeks, followed by 2 mg thereafter, except in patients with a creatinine clearance of 30-50 mL min(-1) or aged ≥ 75 years. The patients received 1.5 mg after the first 7 weeks. The efficacy outcome was the composite of all fatal or non-fatal strokes and systemic embolism. The safety outcome was clinically relevant bleeding (major and clinically relevant non-major bleeding).

RESULTS:

The study was terminated prematurely by the sponsor for strategic/commercial, not scientific, reasons, with 39% of the planned number of patients included and an average duration of treatment of 240 days. Of the 1886 idrabiotaparinux recipients, 20 developed stroke or systemic embolism (1.5% per year), whereas this occurred in 22 of the 1887 warfarin patients (1.6% per year, hazard ratio 0.98, 95% confidence interval 0.49-1.66). The annual incidence of bleeding was 6.1% in the idrabiotaparinux and 10.0% in the warfarin group (hazard ratio 0.61, 95% confidence interval 0.46-0.81).

CONCLUSION:

If anything, despite its early termination, the idrabiotaparinux regimen studied suggested a comparable efficacy to dose-adjusted warfarin, with a lower bleeding risk.

01 May 2013·British journal of clinical pharmacologyQ2 · MEDICINE

Bioequipotency of idraparinux and idrabiotaparinux after once weekly dosing in healthy volunteers and patients treated for acute deep vein thrombosis

Q2 · MEDICINE

Article

Author: Paty, Isabelle ; Cortez, Pierre ; Fau, Jean‐Baptiste ; Trellu, Marc ; Sanderink, Ger‐Jan ; Donat, François ; Cheng, Sue ; Boëlle, Emmanuelle

Aim:

To assess the bioequipotency of equimolar doses of idraparinux (2.5 mg) and idrabiotaparinux (3.0 mg).

Method:

In a phase I study, 48 healthy male volunteers were randomized to a single subcutaneous injection of idrabiotaparinux or idraparinux, followed by plasma sampling over 27 days. In a prospective substudy of the phase III EQUINOX trial, 228 patients treated for acute symptomatic deep vein thrombosis received idrabiotaparinux or idraparinux once weekly for 6 months. Plasma sampling was performed within 5 days following the last injection. The primary pharmacodynamic endpoint was the inhibition of activated factor X (FXa) activity. Maximal anti‐FXa activity (Amax) and area under anti‐FXa activity vs. time curve (AAUC) were calculated. Safety and tolerability were also assessed.

Results:

In both studies, pharmacodynamic anti‐FXa vs. time profiles of idrabiotaparinux and idraparinux were superimposable. Ratio estimates (90% confidence intervals [CIs]) for idrabiotaparinux : idraparinux were 0.96 (0.89, 1.04) for Amax and 0.95 (0.87, 1.04) for AAUC in the phase I study, and 1.11 (1.00, 1.22) for Amax and 1.06 (0.96, 1.16) for AAUC at month 6 in the EQUINOX substudy. Idrabiotaparinux and idraparinux were considered bioequipotent because 90% CIs were within the pre‐specified interval (0.80, 1.25). Study treatments were well tolerated.

Conclusion:

Pharmacodynamic parameters reported after single dose in healthy volunteers and after repeated once weekly dosing in patients demonstrated the bioequipotency of idrabiotaparinux and idraparinux based on FXa inhibition. These outcomes support the use of an idrabiotaparinux dose bioequipotent to an idraparinux dose in large clinical trials, and the possibility to substitute idrabiotaparinux to idraparinux for the treatment of venous thromboembolism.

100 Deals associated with Idrabiotaparinux sodium

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External Link

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Atrial Fibrillation	Phase 3	United States	Sanofi	01 Dec 2007
Atrial Fibrillation	Phase 3	Argentina	Sanofi	01 Dec 2007
Atrial Fibrillation	Phase 3	Australia	Sanofi	01 Dec 2007
Atrial Fibrillation	Phase 3	Austria	Sanofi	01 Dec 2007
Atrial Fibrillation	Phase 3	Belarus	Sanofi	01 Dec 2007
Atrial Fibrillation	Phase 3	Brazil	Sanofi	01 Dec 2007
Atrial Fibrillation	Phase 3	Bulgaria	Sanofi	01 Dec 2007
Atrial Fibrillation	Phase 3	Canada	Sanofi	01 Dec 2007
Atrial Fibrillation	Phase 3	Chile	Sanofi	01 Dec 2007
Atrial Fibrillation	Phase 3	Colombia	Sanofi	01 Dec 2007

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00580216 (Borealis-Atrial Fibrillation Study, Pubmed \| J Thromb Haemost)	Phase 3	Atrial Fibrillation	3,773	Idrabiotaparinux	qdnlnborql(ttdbkxyavw) = nkeoraggxy tugozvygcg (afzwbcgevo )	Positive	01 Jun 2014
				Warfarin	qdnlnborql(ttdbkxyavw) = khqzrxzzam tugozvygcg (afzwbcgevo )
NCT00311090 (Pubmed \| J Thromb Haemost)	Phase 3	Venous Thrombosis	757	Idrabiotaparinux (3 mg)	desxusebzq(drqopsauhk) = uxjjzbajyd skfwcmzbyx (ynjgxtenzl ) View more	-	01 Jan 2011
				Idraparinux (2.5 mg)	desxusebzq(drqopsauhk) = owpkuqaqot skfwcmzbyx (ynjgxtenzl ) View more