When is non-inferiority actually superior? When you're talking about new substitutes for the difficult-to-administer warfarin. So, Pfizer ($PFE) and Bristol-Myers Squibb ($BMY) happily announced today that their anticoagulant drug Eliquis hit its primary goal in a new study: It matched standard treatment for potentially life-threatening blood clots, efficacy-wise. And it beat warfarin on the safety side, with a 69% reduction in the risk of major bleeding.
The AMPLIFY study results put Eliquis on track for broader use. The market for treating these blood clots--in the legs, known as deep vein thrombosis (DVT); and in the lungs, known as pulmonary embolism (PE)--amounts to some 1 million patients per year in Europe and 900,000 in the U.S., Reuters notes. That's not nearly so large as Eliquis' primary use, to prevent stroke in patients with atrial fibrillation. But it is another driver for the blockbuster hopeful.
And Eliquis needs it. The drug hasn't stormed onto the scene, at least so far, despite pre-approval expectations that it would quickly steal market share from its previously approved competitors, Boehringer Ingelheim's Pradaxa and Johnson & Johnson ($JNJ) and Bayer's Xarelto. In April, Pfizer's Geno Germano told investors that Eliquis hasn't lived up to expectations, and analysts have revised their sales forecasts for the drug, predicting slower growth, with 2016 sales amounting to about $615 million.
At the time, Germano said Pradaxa and Xarelto's head start in the market had hurt Eliquis. Pradaxa first hit the market in 2008 to prevent surgery-related blood clots and won its stroke-prevention nod from the FDA in 2010. Xarelto won U.S. approval in 2011, with the stroke-prevention indication OK'd that November. And it's no different in the DVT/PE area. Xarelto won new indications for those maladies late last year, and Pradaxa is up for European approval, with two supporting studies under its belt.
Still, it's early days for Eliquis. It's only been on the market for about 6 months. And Pradaxa's first-to-market status means there's been more time for safety worries to emerge. The entire class differs from warfarin in a key respect: Warfarin has a quick antidote, while these drugs don't, at least not yet. That fact has dogged Pradaxa; the FDA put the drug under review after hundreds of bleeding-death reports, and though the agency backed its continued use, it did add a warning to the drug's label. And now, Pfizer and Bristol-Myers can tout their new bleeding-risk data, which researchers called "statistically significant."
- read the release from Pfizer and BMS
- see the Reuters news
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