When is non-inferiority really superior? once you are talking regarding new substitutes for the difficult-to-administer Coumadin. So, Pfizer ($PFE) and Bristol-Myers Squibb ($BMY) merrily proclaimed nowadays that their medication drug Eliquis hit its primary goal in an exceedingly new study: It matched normal treatment for doubtless severe blood clots, efficacy-wise. And it beat Coumadin on the security aspect, with a sixty nine reduction within the risk of major haemorrhage.
The AMPLIFY study results place Eliquis on target for broader use. The marketplace for treating these blood clots--in the legs, referred to as deep vein occlusion (DVT); and within the lungs, referred to as embolism (PE)--amounts to some one million patients per annum in Europe and 900,000 within the U.S., Reuters notes. that is not nearly therefore massive as Eliquis' primary use, to forestall stroke in patients with arrhythmia. however it's another driver for the blockbuster hopeful.
And Eliquis wants it. The drug hasn't stormed onto the scene, a minimum of to date, despite pre-approval expectations that it might quickly steal market share from its antecedently 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 regarding $615 million.
At the time, Germano aforementioned Pradaxa and Xarelto's advantage within the market had hurt Eliquis. Pradaxa initial hit the market in 2008 to forestall surgery-related blood clots and won its stroke-prevention nod from the office in 2010. Xarelto won U.S. approval in 2011, with the stroke-prevention indication OK'd that November. And it's no completely different within the DVT/PE space. Xarelto won new indications for those maladies late last year, and Pradaxa is up for European approval, with 2 supporting studies underneath its belt.
Still, it's time period for Eliquis. It's solely been on the marketplace for regarding half dozen months. And Pradaxa's first-to-market standing means that there is been longer for safety worries to emerge. the whole category differs from Coumadin in an exceedingly key respect: Coumadin contains a fast curative, whereas these medicine do not, a minimum of not however. That truth has tenacious Pradaxa; the office place the drug underneath review when many bleeding-death reports, and tho' the agency backed its continued use, it did add a warning to the drug's label. And now, Pfizer and Bristol-Myers will tout their new bleeding-risk information, that researchers known as "statistically important."
No comments:
Post a Comment