On Heels Of U.S. Approval, BMS, Pfizer Launch Eliquis Ahead Of Pradaxa In China
This article was originally published in PharmAsia News
Under a global collaboration, Bristol-Myers Squibb will co-commercialize Eliquis with Pfizer, but it must contend with Boehringer’s Pradaxa, which has a wider label in China.
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Bristol/Pfizer’s Eliquis secures an attractive FDA label for atrial fibrillation on three key fronts: superior stroke prevention, reduced major bleeding and reduced all-cause mortality. With its superiority in preventing hemorrhagic strokes, Eliquis has the clear lead in terms of safety. But Boehringer’s competing Pradaxa remains the only new oral anticoagulant with proven superiority for preventing purely ischemic strokes, which is the main goal of atrial fibrillation treatment.
FDA could have concerns about the reported data from the ARISTOTLE trial, either from the bleeding comparisons or the dosing in the warfarin control arm. Missing data is another possible issue, as in the recent “complete response” letter for J&J/Bayer’s Xarelto.