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Clot-fighter Eliquis wins speedy new backing from NICE

Cost-effectiveness agency OK's Pfizer, BMS drug for lucrative stroke prevention use
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Clot-fighter Eliquis won a thumbs up for stroke prevention--courtesy of Pfizer

The U.K.'s cost-effectiveness watchdogs must really like Eliquis. The new blood thinner from Pfizer ($PFE) and Bristol-Myers Squibb ($BMY) won a thumbs-up for stroke prevention, just three months after winning approval for that use in the E.U. It's a nice push forward for the drug, which will be vying for market share against Bayer's Xarelto and Boehringer Ingelheim's Pradaxa.

The National Institute for Health and Clinical Excellence issued final draft guidance backing Eliquis to prevent strokes in patients with atrial fibrillation, an abnormal heart rhythm. The drug was already approved to prevent and treat venous thromboembolism, but the stroke-prevention use is the real prize. It's a much larger market.

Eliquis may be third to reach the market after Pradaxa and Xarelto, but it's been hotly anticipated as clearly superior to warfarin. NICE's Carole Longson said the agency's appraisal committee concluded that Eliquis was "more clinically effective than warfarin" at reducing stroke and systemic embolism, and that the drug "resulted in fewer bleeding events than warfarin," including dangerous bleeding in the skull.

The old standard treatment comes with a host of dosage-tweaking rules, plus interactions with alcohol and food, so it is difficult for patients to take and doctors to manage. Longson cited those difficulties in announcing the Eliquis approval: "The Appraisal Committee heard from patient experts that warfarin can have a greater impact on a person's quality of life than atrial fibrillation itself," she said.

The advent of Eliquis will put Boehringer and Bayer on their toes. The first-to-market Pradaxa now comes with safety warnings, including a caution against its use in people with kidney problems. Worries about bleeding risks have put some doctors off its use, despite the fact that it's seen as no more dangerous than warfarin, because the new-generation anticoagulants don't have quick-acting antidotes as the old drug does. Xarelto won't escape the Eliquis launch unscathed, either, analysts have said.

- get the release from NICE
- read the PharmaTimes story

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