Dive Brief:
- Janssen Research & Development said Feb. 8 that the Phase 3 COMPASS trial evaluating blockbuster blood-thinner Xarelto (rivaroxaban) to prevent major adverse cardiac events, including heart attack and stroke, is being halted earlier than planned because the drug’s effectiveness is so evident.
- Previously, March 2018 was the estimated completion date for the international study, which enrolled 27,400 patients with coronary artery disease or peripheral artery disease.
- "Given the magnitude of effect, Janssen, Bayer and the Population Health Research Institute (PHRI), which collaborated on the COMPASS clinical trial, will offer rivaroxaban to study participants in an open-label extension trial," Janssen said. Initially developed by Bayer, Xarelto is marketed by Janssen in the U.S.
Dive Insight:
Currently, Xarelto is approved by the Food and Drug Administration to reduce the risk of stroke and blood clots in some patients with an irregular heartbeat, among other uses. The drug was being tested on patients with coronary artery disease (CAD) or peripheral artery disease (PAD) in an effort to broaden its use. The study’s early halt was based on the recommendation of its independent data monitoring committee.
Janssen stressed Xarelto’s potential impact given the magnitude of heart health problems: The incidences of coronary artery disease and peripheral artery disease are increasing worldwide, despite effective treatments, and screening studies suggest that 20% of adults over age 55 have evidence of PAD. In the U.S. alone, CAD affects 16.5 million and PAD, more than 10 million.
Patients with either coronary or peripheral artery disease carry significant risk of fatal or debilitating myocardial infarction and stroke, according to Janssen, and rivaroxaban is the only non-vitamin K antagonist oral anticoagulant currently being evaluated for these high-risk patients.
"We are excited about the possibility of making rivaroxaban available to patients with CAD and PAD to reduce their risk of major adverse cardiac events, and look forward to discussing the COMPASS trial data with the U.S. Food and Drug Administration as quickly as possible," said Paul Burton, Janssen’s vice president of medical affairs.
Johnson & Johnson said it plans to present a complete analysis of the trial’s data at a medical meeting in 2017.
This could help Xarelto get an edge up in a complicated and saturated market. While the low-cost generic warfarin is still the go-to for blood thinners, Xarelto, as well as Pradaxa (dabigatran) and Eliquis (apixaban), have been battling for a place in this market. J&J reported U.S. Xarelto sales of $2.3 billion for the full-year 2016 earlier this month.