Pfizer, BMS score FDA hat-trick with another Eliquis approval
- Eliquis was already approved in the EU in July for the treatment and prevention of deep-vein thrombosis (DVT) and pulmonary embolism (PE).
- The FDA's decision to approve Eliquis for DVT/PE treatment is based on the strength of phase III data from the AMPLIFY trial comparing Eliquis with the standard of care (warfarin/enoxaparin).
- Eliquis is also approved for anticoagulation treatment to reduce the risk of blood clots following hip or knee replacement surgery, as well as prevention of stroke in individuals with atrial fibrillation.
Eliquis, an oral factor Xa inhibitor, has proven to be sufficiently safe to gain a total of three different indications, making it a true competitive force against warfarin.
The new DVT/PE indication adds an additional 900,000 people to the target treatment population. Because Eliquis provides an oral treatment option with no need for coagulation testing, it can provide an important therapeutic option for a range of anticoagulation uses in various settings.
- Pharma Times Pfizer/B-MS bloodthinner Eliquis bags third US OK