- In a major approval, Johnson & Johnson's Janssen Pharmaceuticals has picked up a new indication for Xarelto. The drug is the is the first and only Factor Xa inhibitor approved to reduce the risk of major cardiovascular events in people with chronic coronary or peripheral artery disease (CAD or PAD).
- The decision is based on data from the Phase 3 COMPASS trial, which showed Xarelto with aspirin reduced stroke by 42%, cardiovascular death by 22% and heart attack by 14% compared with aspirin alone in this patient group.
- Janssen's partner Bayer gained approval for Xarelto in Europe for this indication in August. The first launch is planned for Germany.
There are currently four oral anticoagulants, known as NOACs, on the market: Xarelto (rivaroxaban) from J&J and Bayer; Eliquis (apixaban) from Pfizer and Bristol-Myers Squibb; Pradaxa (dabigatran) from Boehringer Ingelheim; and Savaysa (edoxaban) from Daiichi Sankyo.
So far, Xarelto is the only one to have picked up this indication.
"Treating patients with aspirin only is simply not enough to address the underlying thrombotic risk that comes with chronic CAD and PAD," said Kelley Branch an associate cardiology professor at the University of Washington, Seattle, in an Oct. 11 statement from Janssen. "As we saw in the COMPASS trial, the dual pathway approach of aspirin and the 2.5-mg, twice-daily dose of Xarelto can help significantly reduce the risk of CV events in these populations."
Xarelto stumbled earlier this year when results from the MARINER and COMMANDER HF trials failed to show expected benefits and risk reductions, including in patients at risk of venous thromboembolism.
However, this new approval provides Xarelto with a differentiator against market leader Eliquis. In the second quarter, Xarelto's U.S. sales were $679 million, nearly a 6% increase from the same quarter in 2017. Eliquis' U.S. sales, meanwhile, were $979 million, up 39% year over year.
Credit Suisse analyst Vamil Divan noted in a recent report that Eliquis accounts for 34% of total novel anticoagulant prescriptions while Xarelto is responsible for 24%. Xarelto's share of the market hasn't changed much this year, due in part to Eliquis showing superiority over warfarin for stroke prevention and bleeding Bristol and Pfizer focusing on the drug's stroke prevention indication.
"In order to compete with Eliquis, Bayer’s Xarelto strategy is to diversify indications and the recent COMPASS approval is expected to expand the potential global addressable patient population by [an estimated] 30 million patients," Divan wrote in the Oct. 12 report, adding that an approval for reducing risk of major cardiovascular events in CAD/PAD populations should lift peak Xarelto sales by $2 billion in 2022.
Chronic CAD and PAD are a result of narrowed or hardened arteries. These affect 26.5 million people in the U.S., increasing their risk of heart attack, stroke and death.