Pfizer and Bristol-Myers Squibb's apixaban has suffered a setback in trials against venous thromboembolism (VTE).
An early evaluation of results from a phase III study investigating the prevention of VTE in patients undergoing knee replacement surgery indicates that the primary endpoint was not met.
The indication is the most advanced of two that the companies are pursuing for apixaban, and the disappointing results will delay its US filing for approval until at least 2010.
But BMS's vice president for research and development Jack Lawrence insisted: "BMS and Pfizer remain enthusiastic and committed to the clinical development programme for apixaban."
The study, ADVANCE-1, failed to show that apixaban, given at a dose of 2.5-mg twice daily, was more effective than the FDA-approved dose of enoxaparin: 30-mg twice daily.
The drug is a novel, oral Factor Xa inhibitor with potential to prevent and treat blood clots in the veins and arteries and the companies say they are considering further clinical work with different protocols in preventing VTE in knee surgery.
Studies in the drug's second potential indication - the prevention of stroke in atrial fibrillation will continue as planned, as will plans for a European licence in VTE.
More
An early evaluation of results from a phase III study investigating the prevention of VTE in patients undergoing knee replacement surgery indicates that the primary endpoint was not met.
The indication is the most advanced of two that the companies are pursuing for apixaban, and the disappointing results will delay its US filing for approval until at least 2010.
But BMS's vice president for research and development Jack Lawrence insisted: "BMS and Pfizer remain enthusiastic and committed to the clinical development programme for apixaban."
The study, ADVANCE-1, failed to show that apixaban, given at a dose of 2.5-mg twice daily, was more effective than the FDA-approved dose of enoxaparin: 30-mg twice daily.
The drug is a novel, oral Factor Xa inhibitor with potential to prevent and treat blood clots in the veins and arteries and the companies say they are considering further clinical work with different protocols in preventing VTE in knee surgery.
Studies in the drug's second potential indication - the prevention of stroke in atrial fibrillation will continue as planned, as will plans for a European licence in VTE.
More
2 comments:
VTE is also know as DVT: deep vein thrombosis. It's an oral low molecualar weight heparin: And Lovenox is the market leader. It's basicially a concentrated form of heparin. If untreated, it can lead to a PE: pulmonary embolism.
So Apixaban was not "better" then enoxaparin.
This means it's as good as enoxaparin AND in my (patient's)eyes as a pill is a great advantage to an injection,
and in addition the bleeding risk is lower than enoxaparin's.
If that's not to be called better ???
Post a Comment