In 2007, New York-based pharmaceutical giants Bristol-Myers Squibb (NYSE: BMY) and Pfizer (NYSE: PFE) formed a deal to develop Bristol’s anti-clotting drug, apixaban (Eliquis). The partnership hit a high point on August 28, when the two companies announced positive results from a Phase 3 trial of the drug in patients with the heart-rhythm disorder atrial fibrillation—data that will be key when they apply for FDA approval later this year.
But an event happening today at the FDA may be equally important to the future of apixaban. An advisory panel to the agency is meeting to discuss rivaroxaban (Xarelto), an anti-clotting drug that Johnson & Johnson (NYSE: JNJ) and Bayer developed. They are hoping to win FDA approval in November to market rivaroxaban to patients with atrial fibrillation.
Both apixaban and rivaroxaban are in a new class of drugs known as “factor Xa inhibitors.” Factor X is one of the enzymes that promotes clotting, so inhibiting it helps to prevent strokes or embolisms—common risks in patients with atrial fibrillation. The two drugs were developed with the goal of offering alternatives to warfarin, a 60-year-old anti-clotting product that can cause dangerous side effects such as severe bleeding.
In an interview yesterday, Jack Lawrence, a VP at Bristol and development lead for apixaban, said he was looking forward to the FDA’s discussion on J&J and Bayer’s competing drug. “There are always learnings in how other sponsors approach the FDA’s questions,” he says. “It will be a fascinating discussion. And sometimes it helps not to be the first to go through that process.”
The FDA review is shaping up to be a painful process for J&J and Bayer. On September 6, the FDA posted a nasty review of rivaroxaban on the Web, the upshot of which was to … Next Page »
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