EMA advisory committee backs addition for Eliquis SmPC

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended an addition to the current Summary of Product Characteristics (SmPC) for US pharma majors Bristol-Myers Squibb (NYSE: BMY) and Pfizer’s (NYSE: PFE) Eliquis (apixaban) stating that “Patients can stay on apixaban while being cardioverted.”

Cardioversion is a procedure that attempts to restore the normal heart rhythm in patients with arrhythmias such as atrial fibrillation (AF). There are 8.8 million people with AF in Europe (1.2 million of whom are in the UK) many of whom undergo cardioversion as part of their management.

The CHMP’s positive opinion was based on a post-hoc analysis of the outcomes of the ARISTOTLE study. ARISTOTLE was designed to evaluate the efficacy and safety of apixaban compared to warfarin for the prevention of stroke or systemic embolism in patients with non-valvular atrial fibrillation (NVAF). In ARISTOTLE, 540 patients underwent 743 cardioversions for NVAF. The outcomes of patients treated with apixaban (n=265) compared to those treated with warfarin (n=275) were assessed in the 30 days following cardioversion attempts. Adverse clinical events occurring after cardioversion were found to be comparable between the warfarin and apixaban groups with no reported stroke or systemic emboli in either group and low observed rates of myocardial infarction, major bleeding or death.