J&J, Bayer's Xarelto scores FDA nod in post-surgery artery disease as partners try to catch up with Eliquis

Xarelto
The FDA’s decision marks Xarelto’s ninth indication and is good news for J&J and Bayer, which are hoping additional indications will help the pair’s anticoagulant catch up with Pfizer and Bristol Myers Squibb’s rival, Eliquis. (Johnson & Johnson)

Trailing a big-selling rival from Pfizer and Bristol Myers Squibb, Bayer and Johnson & Johnson are looking for any opportunity to bolster their aging heart drug Xarelto. Now, just short of its 10th anniversary on the market, Xarelto will celebrate with another FDA win. 

U.S. regulators on Tuesday awarded Xarelto, coupled with aspirin, an expanded approval for patients living with peripheral artery disease, or PAD. The med’s label will now include patients who’ve recently undergone surgery to unblock arteries in their legs because of the disease, known as lower-extremity revascularization (LER). 

The FDA’s decision marks Xarelto’s ninth indication and is good news for J&J and Bayer, which are hoping additional indications will help the pair’s anticoagulant catch up with Pfizer and Bristol Myers Squibb’s rival Eliquis. Xarelto generated $6.93 billion in global sales last year, compared with $9.17 billion for Eliquis.

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PAD is a chronic condition that causes the blood vessels to narrow, reducing blood flow to a patient’s limbs, especially the legs. J&J estimates that roughly 20 million Americans are living with the ailment, but less than half of them—about 8.5 million—have been diagnosed.

About a quarter of symptomatic PAD patients require repeat surgeries to open a blocked leg artery. Those patients are at greater risk of future clots because the body produces excess thrombin, which the body uses to form blood clots, and the clumping of platelets in the blood, Jack Lawrence, M.D., head of global development, cardiovascular & metabolism for Janssen Research & Development, told FiercePharma in May. 

Xarelto was previously approved to reduce the risk of a sudden decrease in blood flow to the legs, major amputation, serious heart problems or stroke in PAD patients. This is the first time it has scored an approval to help those who need the surgery to avoid amputation. 

The FDA based its approval on long-term data from Xarelot’s pivotal trial in the artery disease patients, dubbed Voyager PAD. The 6,564-patient study pinned the twice-daily oral pill alongside low-dose aspirin against aspirin alone.

In the trial, Xarelto plus aspirin cut the risk of a variety of negative clot-related outcomes—acute clots in the limbs, a major amputation for vascular reasons, heart attack, stroke or cardiovascular death—by about 15% compared with aspirin alone, J&J said in a statement.

RELATED: ACC 2021: J&J, Bayer pad case for Xarelto in post-surgery artery disease patients

This marks Xarelto’s first FDA nod since it scored the go ahead in late 2019 to help prevent blood clots for acutely ill patients without a high risk of bleeding during and after hospitalization. 

Even as J&J and Bayer work to improve the sales trends for their drug, they're still trailing Eliquis so far in 2021. Over the first half of 2021, Xarelto has reeled in $1.16 billion, up 6.6% compared with last year, while Eliquis has landed $3.12 billion, up 21.4% year over year.