VTE boost for Eliquis
pharmafile | July 2, 2013 | News story | Research and Development, Sales and Marketing | AMPLIFY, BMS, DVT, Eliquis, Pfizer
Bristol-Myers Squibb and Pfizer’s oral blood thinner Eliquis is as efficient as standard of care and causes less bleeding in patients with acute venous thromboembolism (VTE), according to a new analysis from the companies.
Eliquis (apixaban) on its own was non-inferior to the current standard of care – initial parenteral enoxaparin treatment overlapped with warfarin therapy – in treating the two VTE conditions: symptomatic deep vein thrombosis (DVT) and pulmonary embolism (PE) in the six-month Phase III AMPLIFY trial.
Patients in the Eliquis arm, who received 10 mg twice daily for seven days followed by 5 mg twice daily after the first week, also saw a 69% relative risk reduction for major bleeding, which happened to 0.6% of patients given Eliquis compared with 1.8% of those given current standard of care.
AMPLIFY encompassed nearly 5,400 acute VTE patients and Eliquis as a single agent achieved the primary efficacy endpoint of non-inferiority, when it came to reducing the composite endpoint of recurrent symptomatic VTE or VTE-related death.
This occurred in 59 patients in the Eliquis group (2.3%) and 71 (2.7%) receiving the enoxaparin/warfarin package.
Around a million people in Europe and 900,000 in the US are diagnosed with VTE, and once one has occurred up to 10% of people may have a VTE reoccurrence, which could be fatal.
Based on the encouraging data from this study and an earlier one, AMPLIFY-EXT, the manufacturers plan to start regulatory filings for the initial and long-term treatment of VTE, as well as for extended prevention of recurrent VTE.
Results for the primary efficacy and safety endpoints between patients entering the study with a DVT or a PE were comparable, the firms said.
The findings were published online in New England Journal of Medicine and announced at the 24th Congress of the International Society on Thrombosis and Haemostasis.
“Together these studies represent exciting data in the field of VTE treatment and indicate that apixaban may offer an important potential alternative in both acute and extended anticoagulation therapy for VTE patients,” said lead investigator Giancarlo Agnelli, professor of internal medicine at the University of Perugia in Italy.
The Factor Xa inhibitor is already approved to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation in the US, European Union and Japan – as well as to prevent VTE in patients in Europe who have had a hip or knee replaced.
Adam Hill
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