US regulators have issued a green light for the use of Pfizer/Bristol-Myers Squibb’s bloodthinner Eliquis (apixaban) to treat and prevent deep vein thrombosis and pulmonary embolism, which together affect about 900,000 Americans every year.
Marking its third indication in the country, the drug has now been cleared by the US Food and Drug Administration specifically for the treatment of DVT and PE, and for the reduction in the risk of recurrent DVT and PE following initial therapy.
The decision comes on the back of data from the global AMPLIFY trial, in which a regimen of Eliquis 10mg twice daily for one week followed by 5mg twice daily for six months showed comparable efficacy to the standard of care enoxaparin/warfarin, as well as the AMPLIFY-EXT study, in which the drug showed superiority in the primary safety endpoint of major bleeding.
“Eliquis offers oral dosing, no routine coagulation testing, and does not require the use of a parenteral anticoagulant or bridging during initiation,” said Douglas Manion, head of specialty development at B-MS, explaining the drug’s potential competitive edge over existing treatment.
The approval significantly expands Eliquis’ target population; in the US the drug was previously cleared for reducing the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, and the prophylaxis of DVT, which may lead to PE, in patients who have undergone hip or knee replacement surgery.
European regulators also green-lighted the drug for treatment and prevention of DVT/PE last month.