The Stroke Prevention War is On: FDA Approves J&J/Bayer Contender

Xconomy New York — 

Late Friday, the FDA approved rivaroxaban (Xarelto), a blood-thinning drug made by New Brunswick, NJ-based Johnson & Johnson (NYSE: JNJ) and Bayer. The approval came just two months after an advisory panel to the FDA posted a negative review of the drug, which suggested the companies should have to perform new trials to gain approval for reducing stroke risk in patients with atrial fibrillation. The agency didn’t go so far as to mandate that trial, but it did slap the drug with a “black box”—a prominent warning saying that patients who stop taking it may face an increased risk of stroke. The label also says there is little evidence that rivaroxaban works better than the well-known (and inexpensive) blood thinner warfarin.

The J&J/Bayer product—which is already on the market to reduce the risk of blood clots, deep vein thrombosis, and pulmonary embolism following knee or hip-replacement surgery—will have a significant head start in the atrial fibrillation market over a competing product being developed by New York based drug giants Pfizer (NYSE: PFE) and Bristol-Myers Squibb (NYSE: BMY). That drug, called apixaban (Eliquis) charted positive Phase 3 trial results in August. Bristol and Pfizer plan to apply for FDA approval by the end of this year.

Apixaban and rivaroxaban are in a new class of drugs called “factor Xa inhibitors.” Factor X is an enzyme that promotes clotting, so blocking it helps to prevent strokes or embolisms. Both drugs were developed with the goal of offering alternatives to warfarin, a 60-year-old drug that can cause side effects such as severe bleeding.

No doubt there will be a marketing war among all these New York area companies—and Wall Street analysts are already making bets on how it will shake out. Today Barclays Capital analyst C. Anthony Butler put out a report predicting that Pfizer and Bristol-Myers’ drug would outperform the J&J/Bayer contender despite being late to the market. Apixaban, he wrote, “is the only novel anticoagulant thus far that has demonstrated a significant mortality benefit as compared to warfarin in a clinical trial setting.”

Shares of J&J dropped 1 percent today to $63.56.

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