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Xarelto receives FDA approval

Published on 04/07/11 at 10:38am
Bayer J&J Xarelto (rivaroxaban)

Bayer and Johnson & Johnson’s oral blood thinner Xarelto has been approved in the US for the prevention of deep vein thrombosis after surgery.

Xarelto (rivaroxaban), a Factor Xa inhibitor, is now approved for the prevention of deep vein thrombosis that could lead to a pulmonary embolism in patients undergoing knee or hip replacement surgery in the US, where J&J holds the marketing rights to the drug.

Xarelto received European approval for this indication in 2008, but failed to secure FDA approval a year later – this week’s approval is based on updated information sent to the US regulator in January this year.

Paul Chang, VP of Medical Affairs at J&J’s subsidiary Janssen, said: “Shorter hospital stays following hip and knee replacement surgeries have made the prevention of venous blood clots an outpatient issue, and Xarelto provides a safe and effective oral treatment option that can be easily transitioned from use in hospital to home.”

The approval is based on data from a phase III clinical trial programme that pitted Xarelto head-to-head with Sanofi’s standard subcutaneous treatment Lovenox (enoxaparin) and an extended-duration (five weeks) trial comparing Xarelto with short-duration (two weeks) Lovenox, followed by placebo.

In these trials, Xarelto demonstrated similar safety profiles as Lovenox, including low rates of major bleeding, but is likely to be more attractive for patients as it can be taken orally.

J&J and Bayer are also seeking extra indications for DVT prevention in order to increase Xarelto’s sales potential, and have substantial ongoing global trials investigating these uses.

The drug is part of a new generation of anticoagulants seeking to replace the 65-year old injectable warfarin.

Pfizer and partner BMS have already had their oral blood thinner Eliquis (apixaban) approved in the EU and Boehringer Ingelheim stole a march over both rivals in October last year when the FDA approved its Pradaxa (dabigatran etexilate), for stroke risk reduction in patients with non-valvular atrial fibrillation.

Analysts estimate that these new drugs will reach combined sales of $12 - $20 billion by 2020, with J&J and Bayer’s drug adding around $1.6 billion in annual US sales.

Ben Adams

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