Bristol-Myers' Eliquis gets new FDA nod for use after ortho surgery

FiercePharma file photo

When Bristol-Myers Squibb ($BMY) and Pfizer ($PFE) launched their new anticoagulant, Eliquis, early last year, Wall Street analysts predicted it would be a $3-billion-a-year blockbuster. After more than a year of struggling to reach that goal, the companies got some good news late Friday, when the FDA approved the drug to reduce the risk of blood clots in the legs and lungs following hip or knee replacement surgery.

Eliquis was originally approved to treat stroke in patients with atrial fibrillation. BMS and Pfizer predict this new indication will open up a broader market, because there are 719,000 knee replacements and 332,000 hip replacements in the U.S. alone each year. Patients undergoing those procedures are at high risk for deep vein thrombosis (DVT), which can lead to a potentially fatal clot known as pulmonary embolism.

Eliquis is among a new class of drugs that are being marketed as alternatives to the difficult-to-administer warfarin. But the new product has not been the barn burner that analysts predicted it would be: Eliquis brought in just $146 million for BMS in 2013. The drug has struggled to compete with Boehringer Ingelheim's Pradaxa, and Johnson & Johnson ($JNJ) and Bayer's Xarelto, both of which beat the BMS/Pfizer entrant to the market and had much stronger launches.

Analysts originally believed Eliquis would have some key safety advantages over the competition. For example, both Eliquis and Pradaxa are better than warfarin at reducing stroke, but only Eliquis has been shown to reduce a bleeding side effect and improve mortality. Still, Xarelto has outperformed both of them, largely because Bayer has succeeded in expanding the drug's label to a variety of indications, including DVT. As a result, analysts' projections for 2014 sales of Eliquis have plummeted 60% to $491 million, according to EP Vantage.

BMS isn't just counting on the label expansion to boost sales of Eliquis. It recently launched a major marketing campaign for the drug that includes direct-to-consumer advertising and stepped-up outreach to physicians.

- here's the press release from BMS and Pfizer
- read more at Reuters

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