WASHINGTON, D.C.—Pitted against aspirin in a head-to-head study, Bayer and Johnson & Johnson’s Xarelto significantly reduced the rate of recurrent venous thromboembolism, potentially fatal clots that originate in a vein. It's another set of positive data for the next-gen anticoagulant as it works to strengthen its case against rivals from Bristol-Myers Squibb and Pfizer, Boehringer Ingelheim and Daiichi Sankyo.
Trial investigators released results from a 3,396-patient study, known as Einstein Choice, early Saturday. The study enrolled patients who'd previously suffered a venous thromboembolism (VTE), and was designed to test Xarelto's ability to prevent a recurrence.
The study found that, over a 351-day period, fewer patients in the Xarelto arm suffered a repeat VTE: 1.2% of participants taking 10 mg of Xarelto and 1.5% of those taking 20 mg, compared with 4.4% of participants in the aspirin arm. In the 10 mg Xarelto arm, 13 out of 1127 patients experienced a VTE recurrence, compared to 17 out of 1107 in the 20 mg group and 50 out of 1131 in the aspirin group.
Speaking about the results, Paul Burton, VP of Medical Affairs at Janssen, said the rate of VTE recurrence in the aspirin arm was “very high,” adding that there’s an “important unmet need” in the condition.
“Clearly, we think it’s important data for patients and physicians,” he said in an interview. Now, Janssen will look to ”bring these data to physicians as quickly as possible to allow them new treatment options.”
Worth considering is Xarelto’s list price of $12.93 per tablet regardless of dose, making the drug significantly more expensive than aspirin. That price doesn’t reflect negotiated rebates and discounts, a JNJ spokesperson said.
VTEs are potentially life-threatening, and they're the third most common vascular diagnosis behind heart attack and stroke, according to the American Heart Association.
Bayer and J&J’s med was associated with no increase in bleeding complications compared with aspirin. According to University of Ottawa department of medicine chief Philip Wells, who presented the work, the study was the first to test Xarelto’s ability to prevent VTEs in a head-to-head contest against aspirin.
The results come as J&J and Bayer fight for share in the crowded next-gen coagulant field, squaring off against Boehringer Ingelheim’s Praxada, BMS and Pfizer’s Eliquis and Daiichi’s entrant Savaysa. Last year, BMS’ Eliquis posted 80% growth to $3.3 billion; BI and Daiichi haven’t released full 2016 results.
BMS CEO Giovanni Caforio recently said his company is “relatively close” to stealing the market share lead from Xarelto, but J&J plans to fight that advance with its own efforts. J&J has a number of clinical trials in the works to boost Xarelto’s uses, pharma chairman Joaquin Duato told investors last year. Those trials “have the potential to drive $3 billion to $5 billion in incremental sales” for the drug, Duato said.
According to 2016 VTE treatment guidelines from the American College of Cardiology, Xarelto, Pradaxa, Eliquis and Savaysa are recommended in the condition over warfarin. An NIH meta-analysis found that the new anticoagulants are effective as a long-term treatment, with Eliquis boasting the “most favorable profile” in the group.
Back in 2013, Eliquis outperformed placebo in staving off VTE recurrence in a phase 3 trial incorporating 2,482 patients. It remains the only trial showing a comparable bleed risk between an anticoagulant and placebo.