Xarelto gets EU nod
pharmafile | March 25, 2013 | News story | Sales and Marketing | Bayer, Xarelto
Bayer HealthCare has been given a boost by the recommendation in Europe of its oral blood thinner Xarelto to prevent atherothrombotic events after a serious heart problem.
The CHMP thumbs-up is expected to lead to a positive decision on Xarelto (rivaroxaban) from the European Commission in this indication by June this year.
If approved, Xarelto 2.5 mg twice-daily would be used with standard antiplatelet therapy for the prevention of myocardial infarction, cardiovascular death or stroke after an acute coronary syndrome (ACS) in adults.
ACS is a complication of coronary heart disease, the single most common cause of death worldwide, and occurs when a blood clot blocks a coronary artery, reducing blood supply to the heart.
The EU recommendation will be a relief to the manufacturer: earlier this month the FDA rejected the drug again, issuing a second complete response letter.
Janssen Pharmaceuticals, which markets the brand in the US, received its first letter last June but insists it is still confident, even after the latest setback.
Standard antiplatelet therapy targets platelet activation, which is one way in which clots form, but it does not treat another – thrombin generation.
The Phase III ATLAS ACS 2-TIMI 51 study of more than 15,500 patients demonstrated that the addition of Xarelto 2.5 mg significantly reduced cardiovascular death, myocardial infarction or stroke in patients after a recent ACS compared to standard therapy alone.
Xarelto already has half a dozen indications worldwide, including preventing stroke and systemic embolism in adults with non-valvular atrial fibrillation with one or more risk factors.
It can also be used to treat deep vein thrombosis (DVT), pulmonary embolism (PE) and their recurrence in adults.
Xarelto is also authorised for the prevention of venous thromboembolism (VTE) in patients having hip or knee replacements.
Adam Hill
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