Pfizer and Bristol-Myers Squibb’s next-gen anticoagulant Eliquis grabbed a commanding lead over its competitors—even topping longtime U.S. market leader warfarin. Not content to rest on its laurels, the alliance is now touting a new round of real-world data that could boost its use against older go-to meds in Europe.
In a real-world study of more than 320,000 French nonvalvular atrial fibrillation patients, Eliquis showed a lower rate of major bleeding than standard-of-care vitamin K antagonists (VKA) as well as next-gen rivals Xarelto from Johnson & Johnson and Pradaxa from Boehringer Ingelheim.
Those real-world data, part of Pfizer and Bristol’s Naxos study, were presented Sunday at the European Society of Cardiology Congress in Paris.
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.
Taken together, the data point to Eliquis’ efficacy lead over its competitors—particularly VKAs like warfarin that long held the lead as standard of care for atrial fibrillation, according to Danny Wiederkehr, global team lead for Pfizer’s Health Economics and Outcomes Research Unit. The study also gave researchers a chance to pit Eliquis against non-warfarin VKAs, which are more commonly used in Europe.
“This study is really helpful for French patients and French physicians to compare the standard of care there,” Wiederkehr said. “That was essentially the best case scenario for us.”
Unlike clinical trials, which must incorporate randomization of patient treatment into their methodology, real-world studies like Naxos are limited in their clinical insights and are most often used as companion pieces for trial data.
Wiederkehr pointed to Naxos’ sizable patient pool—321,521—and the lack of a comparable clinical trial as testament to the usefulness of the study’s findings.
“We have millions of patients treated with these products in the real world today—it’s not the exact same thing (as a clinical trial), but we shouldn’t let the available patient data sit there unleveraged. We have a great opportunity to generate head-to-head data.”
With the newest data in hand, Eliquis' makers are hoping to extend the drug's lead over the warfarin alternative market.
In March, Pfizer and BMS released phase 4 data showing Eliquis carreid a lower risk of bleeding and hospitalization than warfarin. Adding Eliquis to P2Y12 antiplatelet therapy—such as Sanofi’s Plavix or its generics—with or without aspirin cut the number of serious bleeding episodes compared with warfarin combination treatment. In the study's Eliquis arm, 10.5% of patients had suffered major or clinically relevant bleeding episodes at the six-month mark, compared with 14.7% of patients in the warfarin arm.
Results such as those have helped Eliquis surge past its non-VKA competitors but also top warfarin in market share. Its commanding lead could put Eliquis’ peak sales at $12 billion by 2024, according to Evaluate Pharma. Those sales would place the drug third on the list of pharma’s biggest sellers by Evaluate’s calculations.