Bayer ($BAYN) and Johnson & Johnson's ($JNJ) Xarelto has notched another victory this month. European regulators have backed the potential blockbuster blood-thinner drug for approval to prevent strokes, Reuters reports. This recommendation paves the way for a potential EU approval of the clot buster for stroke prevention and deep-vein thrombosis.
The drug remains in the running to be among a new class of blood-thinners that give patients an alternative to the old standby for the stroke-prevention population, warfarin. And the higher-cost alternatives are expected to deliver many billions in annual revenue to the pharma industry, which, as we know, has been falling behind in its pursuit of new products to replace revenue from aging brands that are falling prey to generic-drug rivals.
With the EMA's endorsement, Xarelto could gain EU marketing approval for stroke-prevention from the European Commission before the end of the year. After an FDA advisory panel's positive option of the drug for this use earlier this month, the FDA is less than two months away from deciding whether to give the drug a green light for the major stroke-prevention market, giving Bayer and J&J a lead in the race to the market for this indication, ahead of Pfizer ($PFE) and Bristol-Myers Squibb's ($BMY) highly promising candidate for the big atrial fibrillation segment, Eliquis (apixaban). Boehringer Ingelheim has the early market entrant of this hot class of drugs, Pradaxa, but analysts are expecting Eliquis and Xarelto to deliver better results for patients.
Xarelto is already approved for patients who undergo certain surgeries, but the atrial fibrillation market is expected to be the largest driver of revenue for the product if it garners the needed approvals, Bloomberg reports.