BMS, Pfizer Discontinue Trial, Citing Increased Bleeding

Bristol-Myers Squibb (BMS) and Pfizer have discontinued a late-stage clinical trial of the blood-thinner apixaban for acute coronary syndrome (ACS) due to increased bleeding. The Phase III APPRAISE-2 trial was stopped after an independent data monitoring committee found patients randomized to receive apixaban showed an increase in bleeding that was not offset by the drug’s prevention of ischemic events. Despite this setback for apixaban in ACS — one of nine trials of the drug — the companies say they will move forward with a rolling submission to the FDA for the prevention of stroke in patients with atrial fibrillation.
Clinical Trials Advisor