J&J gets key label expansion for its blood thinner Xarelto

By PharmaCompass

2018-10-18

Impressions: 161 Article

Johnson & Johnson and Bayer’s Xarelto, which has been gradually losing market share to Pfizer and Bristol-Myers Squibb’s Eliquis, just won a much-needed new indication. According to analysts, this new indication can bring in US$ 1.5 billion for Xarelto from the US alone.

The US Food and Drug Administration (FDA) approved Xarelto as a drug that can reduce cardiovascular (CV) risks in patients with coronary artery disease (CAD) or peripheral artery disease (PAD), a J&J statement said. That makes it the first novel oral anticoagulant (NOAC) approved for that market, ahead of Eliquis and Boehringer Ingelheim’s Pradaxa.

The drug is the first and only Factor Xa inhibitor (a class of anticoagulant drugs that act directly upon Factor X in the coagulation cascade, without using antithrombin as a mediator) approved to reduce the risk of major CV events in people with CAD or PAD.

This decision of the FDA is based on data from the Phase 3 COMPASS trial, which showed Xarelto with aspirin reduced stroke by 42 percent, cardiovascular death by 22 percent and heart attack by 14 percent compared with aspirin alone in this patient group.

In August this year, Bayer had gained approval for Xarelto in Europe for this indication. The first launch is planned for Germany.

There are currently four 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.

Earlier this year, results from the MARINER and COMMANDER HF trials on Xarelto failed to show expected benefits and risk reductions, including in patients at risk of venous thromboembolism.

This new approval provides Xarelto with a differentiator against market leader Eliquis. In the second quarter, Xarelto’s US sales were US$ 679 million, nearly 6 percent higher than the same quarter in 2017. Meanwhile, Eliquis’ US sales were US$ 979 million, up 39 percent year over year.

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