- According to a new report from EP Vantage, Bayer's Xarelto is set to become top drug by sales in Europe by 2022, with Astellas's Xtandi coming in second.
- Rounding out the top five are Bristol-Myers Squibb's Opdivo, a front-runner in immuno-oncology; Celgene's Revlimid, also a cancer drug; and GlaxoSmithKline's Triumeq, a fixed-dose combination drug for treatment of HIV.
- In contrast to its global forecasts, which peg Humira as the top-selling drug in 2022, EP Vantage estimates Humira will only rank 17th in Europe by then.
Currently, Xarelto is still the top-selling new oral anticoagulant (NOAC) in the US, with roughly $1.83 billion in sales last year, but the risk of bleeds has been challenging for practitioners and patients alike.
Based on data from the US market, the annual rate of bleeds with FXa inhibitors such as Xarelto is in the 1% to 4% range, suggesting an unmet medical need for anticoagulant reversal agents. Between April 2014 and April 2015, there were more than 50,000 Xarelto- and Eliquis-treated patients admitted to hospitals for bleeding.
EP Vantage's forecast for Xarelto is based on the assumptions that a reversal agent specifically for Factor Xa inhibitors will be approved and Xarelto's label will be expanded.
Portola filed a Biologics License Application for its reversal agent andaxenet alfa to the FDA earlier this year, and expects to file in the European market soon.
Although Boehringer Ingelheim's Pradaxa (dabigatran), was the first NOAC approved in 2010, its sales have lagged behind both Xarelto and Eliquis. Boehringer is counting on the reversal agent Praxbind, which was approved in October 2015 to give it a leg up in the market.