J&J, Bayer look to turbocharge Xarelto with new label-expanding studies

Johnson & Johnson ($JNJ) and Bayer's Xarelto already heads up the pack of new-age anticoagulants, but the pair isn't quitting while it's ahead. Instead, the drugmakers are looking to expand that market lead with new clinical trials aimed at widening the drug's label.

The partners will be building out their cardiovascular research program to test Xarelto as a treatment for acute coronary syndrome (ACS), embolic stroke of undetermined source and peripheral artery disease.

An ACS nod alone would be plenty lucrative, with the malady accounting for some 1.1 million hospital admissions annually in the U.S. For that reason, Bayer and J&J have tried for ACS approval three separate times, with the most recent FDA rejection following a resounding 10-0 "no" vote from an advisory committee.

But as The Wall Street Journal notes, if these Xarelto studies--along with the 8 others the companies have started since last March--are successful, the findings could help double Xarelto's list of approved indications, raising the total to at least 12.

That could certainly help increase the gap between Xarelto and its trailers, Boehringer Ingelheim's Pradaxa and third-to-the-party Eliquis, from Pfizer ($PFE) and Bristol-Myers Squibb ($BMY). BI's drug currently boasts just one FDA indication beyond its initial approval for preventing blood clots and stroke in atrial fibrillation patients, while Eliquis tallies two others.

That's not to say Xarelto's competitors aren't hard at work on their own label expansions. Eliquis, for one, just last month racked up an FDA approval to treat deep vein thrombosis (DVT) and pulmonary embolism (PE)--blood clots in the legs and lungs--as well as to cut the risk of recurrent DVT and PE following initial therapy.

Still, Xarelto's rivals haven't been able to touch the sales it's been putting up since it passed first-to-market Pradaxa. In this year's second quarter, the therapy nearly doubled its U.S. top-line haul from the year-ago period to $361 million.

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