Bristol-Myers Squibb and Pfizer drop development of apixaban in acute coronary syndrome, but good news for Pfizer with axitinib

As a result of drug side effects seen in the Phase III APPRAISE-2 clinical trial in patients with recent acute coronary syndrome (ACS) treated with the blood thinner apixaban or placebo in addition to mono or dual antiplatelet therapy, US drug majors Bristol-Myers Squibb (NYSE: BMY) and Pfizer (NYSE: PFE) have discontinued the study for this indication.

The study was stopped early based on the recommendation of an independent Data Monitoring Committee (DMC). There was clear evidence of a clinically important increase in bleeding among patients randomized to apixaban, which was not offset by clinically meaningful reductions in ischemic events.

The APPRAISE-2 Trial (Apixaban for Prevention of Acute Ischemic Events - 2), one of nine clinical trials evaluating apixaban in patients at risk of ischemic events, was designed to include around 10,800 patients with a recent ACS. Patients were randomized to apixaban 5mg twice daily or placebo. The study was conducted in 40 countries and was coordinated by Duke Clinical Research Institute in the USA and Uppsala Clinical Research Center in Sweden. The lead investigators will complete a full evaluation of the available data set and the results will be made public.