Further US approval for Xarelto
pharmafile | November 5, 2012 | News story | Sales and Marketing | Eliquis, FDA, Pradaxa, Xarelto
US regulators have given the go-ahead to expand the indications for which Janssen Pharmaceuticals and Bayer HealthCare’s oral blood thinner Xarelto can be used.
After a fast-track review the FDA has said Xarelto (rivaroxaban) can now treat deep vein thrombosis (DVT), pulmonary embolism (PE) and be used to reduce the risk of these conditions’ recurrence after initial treatment.
The tablet is already approved to reduce the risk of blood clots in the legs and lungs of people who have just had knee replacement surgery, and to reduce this risk in hip replacement patients.
It is also licensed to reduce the risk of both hemorrhagic and thrombotic strokes as well as other blood clots in people with atrial fibrillation (AF) not caused by a heart valve problem.
Its main rivals at present are Pfizer and BMS’ Eliquis and Boehringer’s Pradaxa, which gained US approval in 2010 for use in AF.
Eliquis is still under FDA review but could yet be the biggest-seller of the three, some analysts believe.
The trio are vying to replace standard-of-care warfarin, which has been around for half a century.
The FDA based its latest decision on Xarelto around data from the global EINSTEIN programme, which included three Phase III studies including more than 9,400 patients.
A 15 mg dose is now approved to treat patients with DVT or PE twice daily for three weeks, followed by 20 mg once daily for the remaining treatment period.
When it comes to preventing recurrence, the regime is 20 mg once a day following an initial six months of treatment for acute venous thromboembolism.
Janssen and Bayer are keen to highlight that Xarelto is the only oral anticoagulant approved to treat DVT and PE without the need for injections or routine blood monitoring.
They say this means it has “the broadest profile of any of the new oral anticoagulants in the US market today or coming to market in the foreseeable future”.
Adam Hill
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