|NICE's Carole Longson|
Bayer's Xarelto, which has been cruising along since it joined a new class of warfarin replacement therapies on the market, has faced a rare stumbling block in acute coronary syndrome (ACS)--an indication the FDA has denied it on three separate occasions.
But across the pond, it's picked up a nod in some ACS patients from the U.K.'s cost-effectiveness gatekeeper.
In draft guidance Wednesday, The National Institute for Health and Care Excellence (NICE) gave Xarelto the thumbs up for preventing blood clots in patients who have had heart attacks. In 2009-10 there were 57,000 admissions for heart attacks in England, with 28,000 subsequent heart attacks, the watchdog noted.
"People who have a heart attack are at higher risk of having further events. This can have a negative impact on the quality of life of the person and their family because of worries over their future health. Any additional treatments to reduce that risk are therefore to be welcomed," Carole Longson, the NICE Health Technology Evaluation Centre Director, said in a statement.
It's just another feather in Xarelto's cap; despite hitting the market behind Boehringer Ingelheim rival Pradaxa, Xarelto has raced to the front of the pack thanks to a slew of indications in both the U.S. and EU. Those have helped the drug rack up $1.09 billion through the first 9 months of the year for Bayer partner Johnson & Johnson ($JNJ), which markets the drug stateside.
But so far, ACS is not among them, at least where the FDA is concerned. This February, the agency issued J&J complete response letters in the wake of a unanimous "no" vote from an advisory committee.
That doesn't mean Bayer and J&J have stopped pursuing a U.S. indication in ACS, which accounts for some 1.1. million hospital admissions annually in the U.S. In September, the partners shared plans to build out their cardiovascular research program to test Xarelto as a treatment for the malady, as well as for embolic stroke of undetermined source and peripheral artery disease.
- read the release
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