Janssen Pharmaceutical and Bayer saw the good, the bad and the potential for ugly this week with their blockbuster blood-thinner Xarelto (rivaroxaban). The drug gained approval for a new indication in Europe, failed a late-stage trial and is staring down the barrel of patent loss in 2023 while battling legal threats.
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Janssen Pharmaceutical and Bayer saw the good, the bad and the potential for ugly this week with their blockbuster blood-thinner Xarelto (rivaroxaban). The drug gained approval for a new indication in Europe, failed a late-stage trial and is staring down the barrel of patent loss in 2023 while battling legal threats.
First, the good. Bayer, who markets Xarelto outside of the United States, scored a new indication in Europe for use as a preventative of atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD). The new indication is aimed at those patients who are at high risk for ischemic events, Pharmaletter reported over the weekend. The approval was based on the late-stage COMPASS trial, which last month secured the seal of approval from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). The EMA approved a 2.5 mg twice daily dose of Xarelto plus a once-per-day dose of acetylsalicylic acid (ASA) at 75 to 100 mg for the prevention of atherothrombotic events. Data showed that the use of this combination was able to reduce the threat of stroke, death from a cardiovascular-related event or a heart attack by 24 percent, compared to ASA alone.
That was the good. Now for the bad.
This weekend at the European Society of Cardiology Congress, Janssen and Bayer announced that Xarelto failed to show a significant difference between Xarelto and placebo in the Phase III MARINER trial. The trial showed that Xarelto did not meet the endpoint of reducing venous thromboembolism (VTE), or blood clots, and VTE-related death in acute medically ill patients following hospital discharge, according to a company statement. However, Janssen said that Xarelto did “significantly reduce VTE with consistent safety.” When examining VTE only, Janssen said that fewer events were observed with Xarelto. While the MARINER trial failed to hit its endpoints, Janssen pointed to an earlier trial that showed success with the same patient population of acute medically ill patients, the MAGELLAN trial.
James List, global therapeutic head of cardiovascular and metabolism at Janssen, said the combination of data from MARINER and MAGELLAN tell a “more complete story” about Xarelto’s role in preventing VTE in appropriate acute medically-ill patients who are still in the hospital, as well as those who have been discharged.
“We see a filing pathway towards approval with these combined findings and look forward to discussing them with the U.S. Food and Drug Administration,” List said in a statement.
That was the bad, but here’s where it got a little ugly.
In December 2017, a judge ordered the two companies to pay $28 million to Lynn Hartman and her husband. Lynn Hartman had been taking the drug to treat atrial fibrillation. About a year after being on the medication, she began to experience significant internal bleeding. Once she was taken off the medication, she recovered. Lawsuits similar to the one won by the Hartman family are still awaiting a trial.
Penn Record reported Saturday that Janssen and Bayer are seeking to dismiss about a dozen lawsuits. Attorneys for the two companies argued that the plaintiffs have not complied with filing guidelines. Specifically, attorneys for Janssen and Bayer said some of the plaintiffs have not filed the required fact sheets, while others made “numerous omissions in the filing,” Penn Live reported. A hearing on this request is scheduled for Sept. 6.
