ks1490
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fyi....good news for mech valvers....
Boehringer Wins FDA Approval for First Warfarin Rival (Update1)2010-10-19 22:10:12.105 GMT (Updates with comments from agency in eighth paragraph.)
By Naomi Kresge and Catherine LarkinOct. 19 (Bloomberg) --
Boehringer Ingelheim GmbH won U.S.regulatory approval to sell Pradaxa, a drug that may change theroutines 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 ayear.
The Boehringer pill is better than warfarin, whichrequires 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 arat poison and approved as a medicine in June 1954, to ward offstrokes in 2.2 million Americans with the irregular heartbeatknown as atrial fibrillation. Because of fears of spontaneousbleeding, a known side effect of blood thinners, some patientsaren’t being treated at all, Steven Nissen, head of cardiologyat the Cleveland Clinic, said in the advisory panel meeting.
Pradaxa is already sold in Europe to prevent clots afterhip and knee surgery, as is another potential warfarinreplacement, 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 undergoperiodic monitoring with blood tests, such monitoring is notnecessary for Pradaxa,” Norman Stockbridge, director of thedivision of cardiovascular and renal products for the FDA’sCenter for Drug Evaluation and Research.Bayer, based in Leverkusen, Germany, and New Brunswick, NewJersey-based J&J are expected to present results of a trial ofXarelto against warfarin in atrial fibrillation patients at theAmerican Heart Association conference in November.
Pfizer and Bristol-Myers, both based in New York, aretesting a third experimental warfarin replacement calledapixaban. The two U.S. drugmakers are expected to present trialresults comparing apixaban and warfarin next year.Warfarin replacement will be such a big market that each ofthe competitors may exceed $1 billion in annual sales ifapproved, Fernandez wrote.
Boehringer Wins FDA Approval for First Warfarin Rival (Update1)2010-10-19 22:10:12.105 GMT (Updates with comments from agency in eighth paragraph.)
By Naomi Kresge and Catherine LarkinOct. 19 (Bloomberg) --
Boehringer Ingelheim GmbH won U.S.regulatory approval to sell Pradaxa, a drug that may change theroutines 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 ayear.
The Boehringer pill is better than warfarin, whichrequires 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 arat poison and approved as a medicine in June 1954, to ward offstrokes in 2.2 million Americans with the irregular heartbeatknown as atrial fibrillation. Because of fears of spontaneousbleeding, a known side effect of blood thinners, some patientsaren’t being treated at all, Steven Nissen, head of cardiologyat the Cleveland Clinic, said in the advisory panel meeting.
Pradaxa is already sold in Europe to prevent clots afterhip and knee surgery, as is another potential warfarinreplacement, 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 undergoperiodic monitoring with blood tests, such monitoring is notnecessary for Pradaxa,” Norman Stockbridge, director of thedivision of cardiovascular and renal products for the FDA’sCenter for Drug Evaluation and Research.Bayer, based in Leverkusen, Germany, and New Brunswick, NewJersey-based J&J are expected to present results of a trial ofXarelto against warfarin in atrial fibrillation patients at theAmerican Heart Association conference in November.
Pfizer and Bristol-Myers, both based in New York, aretesting a third experimental warfarin replacement calledapixaban. The two U.S. drugmakers are expected to present trialresults comparing apixaban and warfarin next year.Warfarin replacement will be such a big market that each ofthe competitors may exceed $1 billion in annual sales ifapproved, Fernandez wrote.
