Anticoagulant Eliquis has taken the U.S. warfarin alternative market by storm, passing warfarin itself in the process. But the drug's marketers, Bristol-Myers Squibb and Pfizer, believe advanced screening could identify undiagnosed atrial fibrillation patients—and give the drug another leg up.
The two drugmakers will launch a new randomized study, dubbed Guard-AF, to determine whether early screening for atrial fibrillation in previously undiagnosed patients aged 70 and older could lower the rates of afib-related stroke over standard of care.
Bristol said in a release that afib will affect around 8 million individuals in the U.S. in 2019, and more than 25% of afib-related stroke patients find out they have the condition after the stroke occurs, highlighting the need for effective screening.
Roland Chen, Bristol's vice president and head of clinical development in innovative medicines, called the study potentially "practice informing," giving underdiagnosed patients an early warning for stroke.
"The unmet need in patients is extremely high when you consider many people aren't even aware that they have atrial fibrillation," Chen said. "With Guard-AF, we hope we'll address some questions that don’t have definitive answers now."
Chen said the study will begin enrollment later this year, eventually including 52,000 Medicare patients identified through 300 primary care centers. The study has.a tentative readout date in late 2021, Chen said.
Of course, data supporting the use of early screening could give a big boost to the patient pool for Eliquis, which is approved to reduce the risk of stroke and pulmonary embolism in patients with non-valvular afib.
Eliquis is already a major driver for Bristol after posting a whopping $1.9 billion in global sales in the third quarter, driven by a 30% jump in prescription figures during that time. In the U.S., Eliquis has long since passed other warfarin alternatives like Johnson & Johnson's Xarelto and even warfarin itself.
Back in September, the alliance presented Eliquis real-world data in France showing the drug lowered the rate of major bleeding over standard-of-care vitamin K antagonists (VKA) as well as Xarelto and Boehringer Ingelheim's Pradaxa.
While Eliquis topped its competitors in lowering the rate of major bleeding, though, it showed more scattershot results in the study’s other data sets. In rates of stroke and systemic thromboembolic events, Eliquis beat out VKAs but posted similar rates as Xarelto and Pradaxa. For all-cause mortality rates, Eliquis again topped VKAs and Xarelto but matched Pradaxa.