CHMP recommends Eliquis for recurrent thrombotic events
- BMS and Pfizer have announced that CHMP recommended approval of Eliquis (apixiban) for deep vein thrombosis and pulmonary embolism, as well as the reccurrence of those events.
- CHMP’s positive response is based on two phase III trials comparing outcomes in placebo-treated versus Eliquis-treated patients.
- The primary endpoint was reduction of symptomatic VTE or death. The safety endpoint was major bleeding.
The clinical data set supporting this application is extensive and includes a total of more than 7,800 patients. There were various doses of Equilis tested, as well as placebo, and patients were followed closely. There is clearly a medical need for a clinically proven prevention strategy for recurrent VTE, as 10% of people who experience a VTE experience a recurrence.