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New Drugs Online Report for idrabiotaparinux sodium
Information
Generic Name:
idrabiotaparinux sodium 
Trade Name:  
Synonym: SSR 126517; SSR126517; SSR126517E 
Entry Type: New molecular entity  
 
Developmental Status
UK: Discontinued 
EU: Discontinued 
US: Discontinued 
UK launch Plans: Available only to registered users
Actual UK launch date:  
Comments
Dec 09: development discontinued because of “recent therapeutic advances in the field” [3]. 
22/12/2009 09:15:47
Apr 09: A decision on whether to continue development will be made in the next few months, following a pipeline review (2) 
29/04/2009 18:26:17
Filing for approval for stroke prevention in AF patients expected in 2011 (1). 
23/09/2008 15:31:43
 
Trial or other data
The EQUINOX phase III trial has enrolled 700 patients with DVT of the lower limbs. The study will compare the safety and efficacy of idrabiotaparinux with idraparinux on new events of DVT and PE, and bleeding risk over 6 months. The study will also compare the activities of idrabiotaparinux and idraparinux directly in blood during and after the 6 months of treatment, and whether avidin can reverse the anticoagulant effect of idrabiotaparinux at the end of treatment (1) 
23/09/2008 15:32:47
June 2006: CASSIOPEA III trial started. 3 200 patients with pulmonary embolism randomised to idrabiotaparinux or warfarin. Primary outcome: recurrence of fatal and non fatal venous thromboembolic events (DVT or PE) at 3 months; secondary endpoints include the recurrence of venous thromboembolic events at 6 months, and bleeding over a three to six month period. (1)  
23/09/2008 15:32:30
Idrabiotaparinux sodium is administered once-weekly. It has the same pentasaccharidic structure as idraparinux sodium, but with biotin, which allows rapid neutralisation with avidin to reverse anticoagulant activity.  
23/09/2008 15:32:11
 
Evidence Based Evaluations
NHSC  http://www.pcpoh.bham.ac.uk/publichealth/horizon/outputs/documents/2008/may-august/Idrabiotaparinux.pdf 
   
References  
Available only to registered users
Category
BNF Category:
Parenteral anticoagulants (02.08.01)
Pharmacology: Factor Xa inhibitor  
Epidemiology:  
Indication: Venous thromboembolism (VTE) 
 
Method(s) of Administration
Subcutaneous 
 
Company Information
Name: Sanofi  
US Name: Sanofi  
 
NICE Information
In timetable: No  
When:  /