Boehringer Ingelheim GmbH won U.S. regulatory approval to sell Pradaxa, a drug that may change the routines of millions of patients who now rely on the half- century-old blood thinner warfarin.
The Food and Drug Administration cleared the drug for patients with an irregular heartbeat that may raise the risk of a stroke, the agency said today in a statement.
Boehringer, the world’s biggest family-owned drugmaker, beat Pfizer Inc., Bristol-Myers Squibb Co., Bayer AG and Johnson & Johnson to win U.S. approval for a warfarin replacement, a market Bayer has said may reach $12 billion to $15 billion a year. The Boehringer pill is better than warfarin, which requires regular blood tests to ensure a safe, effective dose, most of the members of an FDA advisory panel said in September.
Pradaxa sets “an extremely high bar” for competitors, Seamus Fernandez, a Boston-based analyst for Leerink Swann & Co., wrote in a note to investors on Oct. 11.
Doctors have relied on aspirin and warfarin, developed as a rat poison and approved as a medicine in June 1954, to ward off strokes in 2.2 million Americans with the irregular heartbeat known as atrial fibrillation. Because of fears of spontaneous bleeding, a known side effect of blood thinners, some patients aren’t being treated at all, Steven Nissen, head of cardiology at the Cleveland Clinic, said in the advisory panel meeting.
Sold in Europe
Pradaxa is already sold in Europe to prevent clots after hip and knee surgery, as is another potential warfarin replacement, Bayer and J&J’s Xarelto.
The FDA approved the medicine in 75-milligram and 150- milligram capsules, the agency said in its statement.
“Unlike warfarin, which requires patients to undergo periodic monitoring with blood tests, such monitoring is not necessary for Pradaxa,” Norman Stockbridge, director of the division of cardiovascular and renal products for the FDA’s Center for Drug Evaluation and Research.
Bayer, based in Leverkusen, Germany, and New Brunswick, New Jersey-based J&J are expected to present results of a trial of Xarelto against warfarin in atrial fibrillation patients at the American Heart Association conference in November.
Pfizer and Bristol-Myers, both based in New York, are testing a third experimental warfarin replacement called apixaban. The two U.S. drugmakers are expected to present trial results comparing apixaban and warfarin next year.
Warfarin replacement will be such a big market that each of the competitors may exceed $1 billion in annual sales if approved, Fernandez wrote.
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