Continuing in tradition, this year’s European Society of Cardiology (ESC) Congress, which was held during August 25-29 in Munich, again witnessed an interesting mix of clinical studies in the cardiovascular arena. The coveted congress had two major trial result read-outs for Xarelto, including the much-awaited results from the MARINER trial which were presented as a part of the Hot Line Session.
MARINER Trial: Xarelto’s second stretch in medically ill patients
The MARINER trial enrolled more than 12,000 patients and evaluated the extended use of rivaroxaban at a once-daily dose of 10 mg in patients hospitalized with an acute medical illness. The trial, which was a second test of Xarelto in medically ill patients after the MAGELLAN trial, failed to meet its primary end point to reduce the risk of a composite of symptomatic venous thromboembolism (VTE) or VTE-related death. Xarelto demonstrated no benefit compared with placebo and this was consistent across various subgroups. Additionally, major bleeding was not statistically significant in the treatment group versus the control group.
Despite the neutral results from the trial, investigators maintain a positive outlook for use of Xarelto in the high-risk patient population. The authors of the study noted during the result presentation that the drug may still be worthwhile in some selected subgroups, based on the exploratory secondary endpoints from the trial. However, they cited that this warrants additional prospective studies to accurately assess patients who are at higher risk of VTE and may benefit from extended thromboprophylaxis.
Portola’s Bevyxxa which was recently launched in the United States for extended thromboprophylaxis in medically ill patients after-hospital discharge was expected to face stiff competition from Xarelto in light of positive results from the MARINER study given Xarelto’s established position in the anticoagulant space. This trial failure can prove to be a good news for Bevyxxa as it has first-to-market advantage and remains the only approved NOAC to address hospital-to-home prevention of VTE in acute medically ill patients.
Unmet need still persists
At Decision Resources Group (DRG), we estimate 20 million acute medically ill patients are at risk of VTE across the G7 countries each year. Primary market research conducted by DRG shows that the thromboprophylaxis for medically ill patients is typically managed with standard injectable enoxaparin, unfractionated heparins, or other LMWHs until either full mobility is restored or the patient is discharged from the hospital. According to thought leaders, none of the traditional therapies are deemed fit to address the need for extended thromboprophylaxis beyond the period of hospitalization, or in cases of patient immobilization. These findings highlight physician concerns that the current prophylaxis regimen is not sufficient to manage this subgroup. Given the less than stellar result from Bevyxxa’s APEX study, the recent failure of Bevyxxa to gain approval in Europe and lack of clinical studies from other NOACs, an unmet need for safe and effective treatment options still persists for this high-risk patient population.
DRG’s take on Xarelto’s performance
From a wider standpoint, Bayer and Janssen have been running an extensive array of label-expansion trials as a part of Xarelto’s lifecycle management program. This strategy was expected to play a vital role in underpinning the ongoing growth of Xarelto as well as counter competition from its rival brands. The company’s effort to expand the growth of its blockbuster anticoagulant seems to have hit a snag with the failure of its three key trials: MARINER study, COMMANDER HF study for heart failure patients and NAVIGATE ESUS study for risk reduction in embolic stroke patients. Having faced a complete washout in this year’s ESC Congress, Xarelto seems to have handed over the baton to its strongest competitor Eliquis which has a distinct advantage of a superior label in its core indications. However, the recent approval of Xarelto in Europe and anticipated approval in the United States for the prevention of atherothrombotic events in patients with coronary artery disease or symptomatic peripheral artery disease is expected to expand Xarelto’s patient base and offset the impact of these trial failures.
With an impending patent expiry starting 2023 in major geographies, and a neck-to-neck competition with Eliquis, it will be interesting to see what strategies Bayer and Janssen will follow to navigate through the tough times and command their top spot again in the anticoagulant space. For a more in-depth analysis of market dynamics and KOL insights on the venous thromboembolism market, please see our market assessment in Venous Thromboembolism | Landscape & Forecast |G7.
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