New Jersey-based drugmaker Johnson & Johnson (JNJ) and its partner, Bayer AG, received approval for a new indication for the controversial anti-coagulant medication Xarelto (rivaroxaban). As of mid-October, it is the sole prescription medication in its class that has been approved to reduce the risk of “major cardiovascular events” (i.e., heart attacks) in patients suffering from chronic coronary or peripheral artery disease. Both of these conditions result from the buildup of plaque on the arterial walls (more commonly known as “hardening of the arteries”), causing reduced blood flow to the heart muscle.

The FDA’s decision was based on data from the 2017 COMPASS clinical trial, demonstrating that patients who took Xarelto in conjunction with aspirin therapy were up to 42 percent less likely to die from a major cardiac event than those who took aspirin alone. This approval follows a similar decision by the European Medicines Agency (EMA) in August.

Xarelto is what is known as a Novel Oral Anticoagulant, or NOAC. Other drugs in this class include Pradaxa (Boehringer Ingelheim), Savaysa (Daiichi Sankyo), and Eliquis (Bristol-Meyer Squibb). They are also labeled as “non-Vitamin K antagonists.” While warfarin, the standard treatment for over 65 years, prevents the action of Vitamin K (an important component in blood clotting), NOACs work by disabling the upstream biological mechanisms that allow blood clots to form in the first place. Unfortunately, there was no antidote for NOACs until recently; even a slight bump or bruising could lead to fatal hemorrhaging.

Eliquis (apixaban) has been Xarelto’s primary market competitor, outselling the latter by over 30% last year. Now, thanks to the FDA and the EMA, Xarelto has a unique new selling point that may increase revenues for JnJ. According to an analyst with Credit Suisse, this move is for that very purpose. In a recent report, Vamil Divan wrote, “The recent COMPASS approval is expected to expand the potential global addressable patient population by [an estimated] 30 million patients.” This approval is expected to result in an increase in sales by as much as $2 billion over the next four years.

Xarelto has had a checkered history and is currently the cause of action in over 21,000 pending lawsuits. Plaintiffs allege that there were other medications available that were as effective in reducing the risk of blood clotting that did not pose the same risk of fatal hemorrhaging. In fact, a recent clinical trial, known as MARINER, failed to demonstrate that Xarelto was effective in preventing blood clotting in patients at risk for venous thromboembolism due to infections, heart failure, stroke, and respiratory disorders.

Another study, based on an analysis of 11,000 patient records, found that the hemorrhaging risk associated with Xarelto was “low” – but this study was funded by Bayer and as of this writing has not been confirmed by independent research. Last year, a clinical study known as NAVIGATOR-ESUS, also sponsored by the manufacturers, was abandoned when it failed to demonstrate that Xarelto was superior to aspirin in the prevention of secondary stroke.

K.J. McElrath is a former history and social studies teacher who has long maintained a keen interest in legal and social issues. In addition to writing for The Ring of Fire, he is the author of two published novels: Tamanous Cooley, a darkly comic environmental twist on Dante's Inferno, and The Missionary's Wife, a story of the conflict between human nature and fundamentalist religious dogma. When not engaged in journalistic or literary pursuits, K.J. works as an entertainer and film composer.