Boehringer Ingelheim GmbH’s Pradaxa, the first drug cleared in the U.S. as an alternative to the blood thinner warfarin, is now recommended by the American College of Cardiology for patients with an irregular heartbeat.
Inclusion in treatment guidelines may help expand sales of Pradaxa, which was approved in the U.S. in October. While doctors aren’t obligated to follow today’s advice, the opinion may influence prescriptions, said Craig January, a professor of medicine and physiology at the University of Wisconsin-Madison, who headed the writing subcommittee for the drug.
“This is actually a very impressive roll-out for a new drug,” January said today in a telephone interview. Doctors are just beginning to gain experience with Pradaxa, and some may opt to wait before prescribing the medicine widely, he said.
The updated treatment guidelines were issued by the Washington-based cardiologists’ group, the Dallas-based American Heart Association and the Washington-based Heart Rhythm Society, according to a statement today.
Pradaxa, or dabigatran, is the first new blood thinner to win Food and Drug Administration approval in a market that Bayer AG estimates may surpass $14 billion in sales. Bayer, based in Leverkusen, Germany, and New Brunswick, New Jersey-based Johnson & Johnson have developed a competing drug called Xarelto.
Demand for Boehringer’s new pill shows there is likely to be room in the market for experimental rivals such as apixaban, from Bristol-Myers Squibb Co. and Pfizer Inc., and betrixaban, from Merck & Co. and Portola Pharmaceuticals Inc., Chris Schott, a New York-based analyst for JPMorgan Chase & Co., wrote in a note today to investors.
Bristol-Myers and Pfizer are based in New York, while closely held Boehringer has its headquarters in Ingelheim, Germany. Warfarin has been used as a blood thinner for more than 50 years. Now a generic drug, warfarin also is still sold by Bristol-Myers as Coumadin.
Doctors have sought an alternative to warfarin that is safer and doesn’t require blood tests to monitor levels of the drug. Patients taking warfarin are vulnerable to uncontrollable bleeding or deadly clots at too high or low a dose.
More than half the cardiologists that Boehringer is targeting have written at least one prescription for Pradaxa, said Wa’el Hashad, the company’s vice president of cardiovascular and metabolic disorders marketing, in a telephone interview.
“We expect this year to be a significant year of growth,” Hashad said. He declined to give a sales projection.
Pradaxa and Xarelto, Bayer and J&J’s pill, “will alter care significantly,” Douglas Zipes, a professor emeritus at the Indiana University School of Medicine, in Indianapolis, said in a telephone interview.
“I personally have started switching my patients” to Pradaxa, Zipes said.
To contact the reporter on this story: Naomi Kresge in Berlin at firstname.lastname@example.org