Boehringer Wins FDA Approval for First Warfarin Rival

Boehringer Ingelheim GmbH won U.S. approval to sell Pradaxa, beating drugmakers including Bayer AG and Johnson & Johnson to the market with the first rival to 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 yesterday in a statement.

Pfizer Inc., Bristol-Myers Squibb Co., Bayer and J&J were racing Boehringer, the world’s biggest family-owned drugmaker, to win U.S. approval for a warfarin replacement, a market Bayer has said may reach $12 billion to $15 billion a year. Pradaxa sales may reach $4 billion a year by 2020, according to an estimate from Jack Scannell, a London-based analyst for Sanford C. Bernstein Ltd.

The approval “crystallizes what was already expected to be a high hurdle” for competitors including Bayer and J&J’s drug Xarelto, Scannell wrote in a note to investors today.

Boehringer will start selling Pradaxa in the U.S. within days and will market the blood thinner as reducing the risk of a stroke more than warfarin, Wa’el Hashad, vice president of cardiovascular and metabolic disease marketing, said in a telephone interview today.

“We believe Pradaxa will be a blockbuster product,” Hashad said, using industry parlance for medicines with annual sales of more than $1 billion. The Ingelheim, Germany-based company declined to provide specific sales or market estimates.

Bayer fell 1.3 percent, or 71 cents, to 54.18 euros in Frankfurt trading.

Rat Poison

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 at an FDA advisory panel meeting in September.

The Boehringer pill is better than warfarin, which requires regular blood tests to ensure a safe, effective dose, most of the advisory panel members said.

Pradaxa is already sold in Europe to prevent clots after hip and knee surgery, as is Xarelto.

The FDA approved the Boehringer medicine in 75-milligram and 150-milligram capsules, the agency said in its statement.

Monitoring Unnecessary

“Unlike warfarin, which requires patients to undergo periodic monitoring with blood tests, such monitoring is not necessary for Pradaxa,” said Norman Stockbridge, director of the division of cardiovascular and renal products for the FDA’s Center for Drug Evaluation and Research.

Competitors may benefit because the lower dosage was approved specifically for patients with severe kidney impairment and isn’t likely to be used as a tailored dosage for people who face a lower stroke risk, Scannell said in his note.

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, Seamus Fernandez, a New York-based analyst for Leerink Swann & Co., wrote in a note to investors on Oct. 11.

To contact the reporters on this story: Naomi Kresge in Berlin at nkresge@bloomberg.net; Catherine Larkin in Washington, D.C. at clarkin4@bloomberg.net

To contact the editors responsible for this story: Phil Serafino at pserafino@bloomberg.net; Reg Gale at rgale5@bloomberg.net

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