FDA OKs Xarelto But Adds A Black Box Warning

FDA OKs Xarelto But Adds A Black Box Warning

November 7th, 2011 // 1:23 pm @

In a move that is a win for Bayer and Johnson & Johnson, the FDA has approved their Xarelto bloodthinner for atrial fibrillation, an action that was not expected so quickly, given that questions were raised by an advisory panel last month about moving patients off the treatment.

For this reason, the FDA added a black box warning so that people would not stop usage without consulting their doctors. since this may increase their risk of stroke (you can read the label here and this is the FDA statement). However, “we do not believe this is a major issue because the statement on discontinuing applies to all anticoagulants,” writes Wells Fargo Securities analyst Larry Biegelsen in a note.

The approval sets the stage for a slugfest in the market for bloodthinners, which some analysts have estimated may eventually mushroom into as much as $15 billion annually, since warfarin is decades old and the various drugmakers set to compete will work hard to find new patients. Atrial fibrillation, by the way, occurs in more than 2 million Americans and is a common type of abnormal heart rhythm

Already, Boehringer Ingelheim has been aggressively promoting its Pradaxa bloodthinner. And recently, Pfizer and Bristol-Myers Squibb released Phase III resultsl for their forthcoming Eliquis bloodthinner, which strongly suggested the drugmakers have a treatment that will surpass the rival meds. And the language in the Xarelto label should allow Eliquis to dominate the market, according to ISI Group analyst Marc Schoenebaum.

Moreover, Pfizer and Bristol-Myers are expected to have a huge advantage with their experience selling cardiovascular meds, notably Lipitor and Plavix. Xarelto, though, will be the only one of the three bloodthinners to offer once-daily dosing, a presumed advantage for patient compliance.

However, a key Xarelto clinical trial enrolled higher-risk patients, and the efficacy endpoint was measured after patients were crossed back to warfarin near the end, which Bayer and J&J previously argued led to an increase in last-minute strokes that produced less than stellar results. One analyst called this a roll of the dice, since the decision led to weaker efficacy results.

Source: Pharmalot


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