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European licence for BMS/Pfizer's Eliquis in DVT and PE

Anticoagulant catches up with Bayer's Xarelto and Boehringer's Pradaxa

Bristol-Myers Squibb's and Pfizer's Eliquis (apixaban) 

Bristol-Myers Squibb's and Pfizer's Eliquis has been approved in Europe to treat deep vein thrombosis (DVT) and pulmonary embolism (PE), and the prevention of their recurrence.  

An oral selective Factor Xa inhibitor, Eliquis (apixaban) does not yet have the green light in the US for these indications, although the drug is authorised for several other uses, including stopping VTE in patients who have had hip or knee replacements.  

The European approval was based on the phase III AMPLIFY trial, which showed Eliquis was non-inferior in treating recurrent VTE and VTE-related death, and statistically superior in the primary safety endpoint of major bleeding versus warfarin and enoxaparin - the active ingredient in Sanofi's out-of-patent anticoagulant Lovenox.  

Steve Romano, Pfizer's head of Medicines Development Group for Global Innovative Pharmaceuticals, called it an “important milestone”.  

The decision puts Eliquis on a par with Bayer's Xarelto (rivaroxaban), which has been had a European licence for DVT and PE since 2012, and Boehringer Ingelheim's Pradaxa (dabigatran), which gained the indications just last month.  

Every year approximately one million patients in the EU are diagnosed with VTE - and once a VTE has occurred, approximately 33 per cent of patients may experience a recurrence within ten years.  

In a second late-stage trial, AMPLIFY-EXT, Eliquis was superior in reducing VTE and all-cause death with no statistical difference in major bleeding events versus placebo.  

AMPLIFY looked at nearly 5,400 patients randomised to treatment with Eliquis 10mg twice daily for seven days followed by a 5mg dose twice a day for six months - or enoxaparin 1mg/kg twice daily subcutaneously for at least five days and warfarin orally for six months.  

AMPLIFY-EXT took in almost 2,500 patients - a third of whom took part in AMPLIFY - who were given Eliquis 2.5 or 5mg twice a day, or placebo for 12 months following six to 12 months of initial anticoagulant treatment.  

Eliquis is already approved in Europe to prevent stroke and systemic embolism in adults who have non-valvular atrial fibrillation (NVAF) with one or more risk factors.

Article by
Adam Hill

30th July 2014

From: Sales



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