Bayer gets positive ruling from NICE on Xarelto
NICE originally ruled against the drug but requested additional information on the cost-effectiveness of the anticoagulant, which is part of a new field of warfarin alternatives. Commissioners said the new data was just what they needed, reports Pharmaceutical Field.
NICE has already approved Pradaxa, Boehringer Ingelheim's first-to-market drug in the category. A number of the drugs have been jockeying for market share with similar treatments. Pradaxa and Xarelto have both been approved by the FDA for stroke prevention in patients with an abnormal heart rhythm known as atrial fibrillation, and Xarelto is also approved to reduce clotting risk in certain surgery patients.
Pfizer ($PFE) and Bristol-Myers Squibb ($BMY) expect to muscle into the market with Eliquis, which has some of the strongest data among the contenders. But the FDA recently delayed its decision for three months so it can review additional information.
Pradaxa has been on the market months longer than Xarelto, and so far the Boehringer drug is holding its own with the biggest share of the market. But recent reports of serious bleeding in some patients prompted European regulators and Boehringer to advise caution on its use in some patients.
- here's the Pharmaceutical Field story