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Bayer wins EU watchdog's endorsement for wider Xarelto use
[FRANKFURT] Bayer won the European Medicines Agency's (EMA) recommendation for widening the use of its blockbuster clot prevention drug Xarelto to include atherosclerosis patients, opening a potentially lucrative new market.
The German drugmaker, which bought US seed maker Monsanto, has said about 30 million additional patients could potentially benefit from the drug if the wider use gets the nod.
That would come on top of a population of roughly 25 million patients in atrial fibrillation, which is currently Xarelto's most lucrative market segment, though atherosclerosis patients will be treated at a lower dose and together with aspirin.
The European Commission has the final word on drug approvals in the EU but it typically follows the EMA's endorsements.
Bayer chalked up 3.3 billion euros (S$5.23 billion) in Xarelto revenues last year and expects annual sales to rise above 5 billion euros.
The potentially new use would be for prevention of blood clots in high-risk patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD).