Bayer promotes Xarelto benefits
pharmafile | June 15, 2015 | News story | Sales and Marketing | Bayer, Eliquis, Xarelto, blood, law suits, rivaroxaban
Bayer HealthCare is releasing new evidence to suggest that the risk of taking its best-selling blood thinner Xarelto is outweighed by the health benefits.
Xarelto (rivaroxaban) is facing a series of lawsuits in the US over internal bleeding problems in patients who have taken its oral Factor Xa inhibitor. The company has consistently maintained that the side effects of the medicine were communicated clearly to doctors and patients.
Xarelto – which is co-produced with Janssen – is vital to Bayer’s fortunes: it is the group’s biggest pharma product, rising 38% to €482 million in the latest quarterly results, although this was below analysts’ estimates.
In addition to the legal rumblings around risk, the brand is facing stiff competition from Pfizer’s strong-selling Eliquis (apixaban), so any information which helps bolster its clinical case is welcome for the German company.
The new data will be presented at the XXVth Congress of the International Society on Thrombosis and Haemostasis (ISTH) in Toronto, Canada – which begins this weekend.
It consists of new analyses from the EINSTEIN clinical trial programme, which the company says will provide further data regarding the positive benefit/risk profile of Xarelto in specific patient populations.
These include figures on independent predictors of poor Vitamin K Antagonist control in venous thromboembolism (VTE) patients and hormonal therapy and the risk of recurrent VTE in women receiving anticoagulant treatment.
The new analyses will also reveal that fixed dose Xarelto treatment for VTE is not associated with increased recurrent VTE or major bleeding in patients with a high or low body weight, Bayer says.
The firm is also making available observational data from an independent study in the UK which it believes provide real life insights into the risk of VTE in patients with active cancer.
This should provide doctors “with a broader understanding of blood clot management in everyday clinical practice”, the company suggests, including on unmet needs in this patient population.
Two oral presentations at ISTH from the independent GARFIELD-AF Registry (Global Anticoagulant Registry in the FIELD) will provide new real life data in stroke prevention in patients with newly diagnosed atrial fibrillation (AF) and one or more additional investigator-determined risk factors for stroke.
Bayer and Janssen have recently announced the CALLISTO clinical research programme, which will look at the potential benefits of Xarelto for the prevention and treatment of pulmonary embolism (PE) and deep vein thrombosis (DVT) in patients with various types of cancer.
Adam Hill
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