A couple of months ago, Boehringer Ingelheim grabbed a pair of new FDA approvals for clot-fighter Pradaxa in patients with deep vein thrombrosis (DVT) and pulmonary embolism (PE). And now, it's following up with a DVT/PE approval in Europe: The European Commission (EC) has green-lighted the drug to treat and prevent the recurrence of those dangerous conditions, a nod that will boost Pradaxa as it battles it out in the anticoagulant market.
The EC based its approval, announced Friday, on results from three Phase III trials demonstrating Pradaxa's efficacy compared with old standard warfarin. In those studies, Pradaxa patients experienced significantly lower rates of bleeding than those taking warfarin, and Boehringer's drug also cut the risk of recurrent blood clots by 92% compared with placebo in a fourth trial, the company said.
"We are delighted with the European Commission's decision to approve Pradaxa for DVT and PE patients, confirming the well-studied efficacy and safety profile of Pradaxa, which has been established in a clinical trial program in close to 10,000 patients for DVT and PE, and over 40,000 patients across different indications," BI Chief Medical Officer Klaus Dugi said in a statement.
|BI CMO Klaus Dugi|
That safety profile has been called into question more than a few times. Late last month, Boehringer forked over $650 million to wrap up thousands of lawsuits claiming Pradaxa caused serious--and at times even fatal--bleeding in some patients. While the German drugmaker stood behind the med's safety, the deal allowed it to dodge the expense and effort of long-running litigation, it said.
New FDA data from an extensive look into the drug's side effects show that it does have a lower risk of clot-related strokes, bleeding in the brain, and death than warfarin. But warfarin isn't Pradaxa's main competition. The treatment is part of a three-horse race with Xarelto, from Johnson & Johnson ($JNJ) and Bayer, and Eliquis, from Pfizer ($PFE) and Bristol-Myers Squibb ($BMY).
And while Pradaxa was the first of the next-gen anticoagulants to arrive on the scene, it no longer has the market edge. Xarelto leads the trio in indications and holds the class' largest share of prescriptions, despite data that suggests Eliquis is the safest of the bunch.
- read the release
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