BMS, Pfizer blood thinner meets main phase 3 goal

Phase 3 clinical trial results of Bristol-Myers Squibb and Pfizer's blood thinner, Eliquis, have been announced.

The results showed that Eliquis (apixaban) is as effective as the current standard of care in treating a life-threatening condition called acute venous thromboembolism (VTE), which encompasses two serious conditions: symptomatic deep vein thrombosis (DVT) and pulmonary embolism (PE).

The six month trial, Amplify, evaluated Eliquis in 5, 395 patients and reached its primary efficacy endpoint of noninferiority to current standard of care (initial parenteral enoxaparin treatment overlapped with warfarin therapy) in the reduction of the composite endpoint of recurrent symptomatic VTE or VTE-related death.

Eliquis also met the primary safety endpoint of superiority for major bleeding, with a 69% relative risk reduction (RRR) compared to current standard of care.

"The study results showed that apixaban, as a single-agent, has comparable efficacy with significantly fewer major bleeding events with respect to the standard of care. These results complement the previously published results for the AMPLIFY-EXT study. 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."

Dr. Giancarlo Agnelli, professor of internal medicine, University of Perugia, Italy; director of the Department of Internal and Cardiovascular Medicine and Stroke-Unit, University Hospital, Perugia, Italy; and lead investigator of the study.

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 (ISTH).

Around 900,000 patients in the US and approximately 1 million patients in the EU are diagnosed with VTE every year. Once a VTE has occurred, up to 10% of people may have a VTE reoccurrence, which could potentially be fatal.

Based on these phase 3 results, Bristol-Myers Squibb and Pfizer plan to start regulatory filings for the initial and long-term treatment of VTE, as well as for extended prevention of recurrent VTE.