| Information |
Generic Name: |
idrabiotaparinux sodium
|
| Trade Name: |
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| 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 |
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| References |
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| Available only to registered users |
Uk Medicines Information 