Today is a big day for Boehringer Ingelheim. The FDA’s Cardiovascular and Renal Drugs Advisory Committee is reviewing its Pradaxa drug, which the German drugmaker hopes will win an endorsement for treating stroke prevention in patients with atrial fibrillation. That outcome appears highly likely, given that FDA reviewers took the unusual step of saying the med should be approved - albeit for only one of two doses sought by BI and without a superiority claim over Warfarin, the standard but difficult-to-take treatment (see the briefing documents here).
But what does this mean for the competition? You may recall that several other large drugmakers are racing to get their own bloodthinners into the hands of the nation's doctors - Bristol-Myers Squibb and Pfizer are developing apixaban, which scored well in a recent study (see here) with more to come next year, and Bayer and Johnson & Johnson have Xarelto; widely anticipated study results are due in November. At stake is market worth anywhere from $10 billion to $12 billion annually, depending upon whose estimate you believe. So what are the wags saying?
Even with an FDA recommendation, Boehringer may find that marketing Pradaxa against Xarelto will be challenging. Why? In a research note, Larry Biegelsen of Wachovia Securities points out that Bayer and J&J are seeking approval for only one dose of Xarelto. And so, "if the FDA advisory committee recommends approval of only the 150mg dose of Pradaxa," he writes, "the playing field will be more level for Xarelto because we believe Xarelto has a much greater chance of matching the efficacy and safety profile of the 150mg dose of Pradaxa than it does of matching the 110mg dose." Remember taht docs like flexibility when it comes to dosing. And the 110 mg does was not recommended by FDA staff.
He goes on to speculate that forthcoming Xarelto study results could pressure Pradaxa further, assuming that Xarelto demonstrates better efficacy and comparable safety to warfarin. Xarelto would have such advantages as more convenient dosing (once daily versus twice daily), better tolerability, and no myocardial infarction (MI) signal, which is an assumption on his part.
Meanwhile, Credit Suisse analyst Catherine Arnold wrote to investors that Boehringer's decision to submit an open label study is a gamble. The FDA reviewers, as noted already, declined to endorse a superiority claim, which means that Pradaxa will be at a disadvantage if rival meds "show superiority in a blinded trial and get that in their label." She also points out that, in Canada, where both Pradaxa and Xarelto are already available for acute settings following hip surgery, Xarelto "has proven to be the drug of choice based on clinical data," and has taken a 35 percent share of the market.