Pfizer and Bristol-Myers Squibb have reported that an extra year of treatment with their anticoagulant Eliquis (apixaban) safely reduces long-term risk in patients suffering from venous thromboembolism (VTE).
The results of the phase III AMPLIFY-EXT trial showed that two doses of Eliquis (2.5mg or 5mg twice-daily) reduced the risk of recurrent VTE or death from any cause over the 12-month period, without raising the risk of major bleeding or clinically important minor bleeds.
The data suggest that patients could benefit from extended treatment with the Factor Xa inhibitor beyond its current approved use in Europe for the prevention of VTE in adults who have undergone elective hip or knee replacement surgery.
The trial included nearly 2,500 patients who had already completed 6 to 12 months of anticoagulation treatment for VTE, including deep vein thrombosis (DVT) or pulmonary embolism (PE). After the 12-month extension phase the risk of recurrent VTE or death was 11.6 per cent in the placebo group, 3.8 per cent for the 2.5mg Eliquis group and 4.2 per cent for patients on 5mg of the drug.
The data were presented at the American Society of Hematology (ASH) meeting over the weekend and simultaneously published in the New England Journal of Medicine (NEJM).
“For patients with venous thromboembolism for whom there is uncertainty about the benefits and risks of continued therapy, the results of this study provide a rationale for continuing anticoagulation therapy for an additional 12 months,” write the study authors in the NEJM.
“Both the 2.5mg twice-daily regimen of apixaban and the 5mg twice-daily regimen were effective, safe, and simple to use,” they added.
Eliquis recently had its indications extended to include the prevention of stroke and systemic embolism in adults with atrial fibrillation (AF), putting it on track to achieve blockbuster sales, and the new indication could provide additional upside if approved. Analysts have suggested Eliquis revenues could top $5bn at peak.
Pfizer and BMS have not said what their plans are for extending the indications for Eliquis into long-term VTE treatment, and they are still trying to secure US approval for the drug in AF. Eliquis is also being tested against warfarin as a primary treatment for VTE.
The drug is currently competing in the marketplace against other new-generation anticoagulants such as Bayer’s Xarelto (rivaroxaban) and Boehringer Ingelheim’s Pradaxa (dabigatran), which are seeing strong uptake as data suggests they are easier to administer and safer than warfarin.
All three drugs could also face competition in the next couple of years from Daiichi Sankyo’s edoxaban, another factor Xa inhibitor which is currently in phase III testing in AF with results due in 2013.