BMS and Pfizer will file apixaban in Europe next year
pharmafile | December 8, 2009 | News story | Sales and Marketing | BMS, Pfiizer, Pfizer, VTE, apixaban
Bristol-Myers Squibb and Pfizer are to submit their new anti-clotting drug for European approval in the first half of next year.
Apixaban is aimed at preventing venous thromboembolism (VTE) in patients who have had orthopedic surgery.
It has not been plain sailing for the novel, selective Factor Xa inhibitor, with the companies delaying US filing in the wake of disappointing results from last year’s phase III ADVANCE-1 study.
These failed to show that 2.5-mg twice daily was more effective than the FDA-approved dose of Sanofi-Aventis’ Clexane (enoxaparin), which is 30-mg twice daily.
Despite this setback, the companies insisted they were committed to the drug’s development programme to prevent and treat blood clots in the veins and arteries.
The European application is based on results from the ADVANCE-2 and ADVANCE-3 trials, which evaluated apixaban against the European dosing regimen of enoxaparin.
Results from ADVANCE-2 were presented in July, while ADVANCE-3 data will be submitted next year.
Studies in the drug’s second potential indication – the prevention of stroke in atrial fibrillation – are continuing, with phase II data last year in acute coronary syndrome (ACS) patients providing some hope of success.
APPRAISE-1 compared the current standards of care for ACS, including aspirin and Sanofi/BMS’ Plavix (clopidogrel), and suggested that adding apixaban on top of these may reduce the risk of a second heart attack, stroke or death.
BMS and Pfizer teamed up in 2007 in a global collaboration to develop and commercialise apixaban, which was discovered by BMS.
There is currently some movement in the selective Factor Xa inhibitor class, with Merck signing a similar deal with Portola Pharmaceuticals’ for the latter’s anticoagulant betrixaban earlier this year.
It is currently in phase II clinical development for the prevention of stroke in patients with atrial fibrillation.
The trade-off with anticoagulants tends to be an increase in bleeding versus a reduction in risk.
However, in September Boehringer Ingelheim unveiled new data for its blood-thinner Pradaxa, showing it reduces the risk of stroke compared to warfarin, with no increased risk of bleeding.
This could hurry Pradaxa (dabigatran etexilate) through approval in this indication ahead of apixaban, betrixaban and Bayer and J&J’s Xarelto (rivaroxaban).
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