- Bristol-Myers Squibb Co. and Pfizer Inc. may have a new card to play in marketing the blood thinner Eliquis, unveiling Monday new data exploring use of the oral anticoagulant in patients with non-valvular atrial fibrillation who are undergoing a heart rhythm procedure known as cardioversion.
- Results from the open-label EMANATE study found Eliquis to be as safe as standard therapy of heparin and/or a vitamin K antagonist like warfarin in reducing the risk of stroke in the cardioversion setting. Notably, Eliquis' more rapid onset of action enabled earlier treatment of atrial fibrillation with cardioversion.
- "These exploratory data offer preliminary insights into the potential effects of Eliquis in this high-risk clinical setting," Christoph Koenen, development lead for Eliquis at Bristol-Myers, said in a statement about the EMANATE study.
Bristol-Myers Squibb and Pfizer have been conducting follow-up studies and real-world analyses of Eliquis (apixaban) in an effort to expand use of the drug and address lingering concerns physicians may have with using new oral anticoagulants like Eliquis.
EMANATE was designed to help answer the question of whether Eliquis would be equally as safe as standard therapies in anticoagulating patients before cardioversion.
In the 1,500-person study, no patients receiving Eliquis suffered a stroke or systemic emboli while six strokes occurred in the standard-of-care group. Additionally, fewer patients experienced a major bleed while on Eliquis compared to those given heparin with or without warfarin.
The study was not powered to detect statistically significant differences in bleeding rates or strokes between the two groups, as the advantage of Eliquis over warfarin on both metrics has already been proven by earlier studies.
Cardioversion aims to restore the heart's normal rhythm in patients with atrial fibrillation and can be done either pharmacologically or through electric shock. The procedure, however, can potentially unseat a blood clot in the heart that could then travel to other areas and lead to stroke or embolism. In order to lessen this risk, patients undergoing cardioversion are typically anticoagulated with heparin or warfarin for three weeks prior to the procedure.
Some patients need more immediate cardioversion, though, and are unable to wait three weeks. Unlike standard therapies, Eliquis can be given with a loading dose two hours before performing cardioversion if no existing clots are detected through imaging.
Michael Ezekowtiz, professor of medicine in the Sidney Kimmel Medical College at Thomas Jefferson University, said these findings could appeal to physicians who want the flexibility to immediately cardiovert a patient at higher risk.
Bristol-Myers' Koenen said the companies would share this information with regulators to discuss how it might be added to Eliquis' label, although in a statement he emphasized that further study will be needed to "better understand anticoagulation for early cardioversion."
Bristol-Myers and Pfizer are also building out real-world evidence for Eliquis in high-risk patients with non-valvular atrial fibrillation — part of efforts to reinforce the drug's clinical profile and provide further evidence of value. Analysis presented Monday of four U.S. insurance claims databases found Eliquis to be associated with a lower risk of stroke, embolism and and major bleeding compared to warfarin.
The atrial fibrillation market makes up the lion's share of Eliquis revenues, although the drug is also indicated to treat deep vein thrombosis and pulmonary embolism in certain settings. Sales booked by Bristol-Myers Squibb for Eliquis rose 51% year over year in the second quarter to $1.2 billion.
Investment bank Cowen & Co. forecasts Eliquis sales to reach $4.8 billion in 2017 and $5.6 billion in 2018, helping drive revenue growth for both Bristol-Myers and Pfizer.