Antiphospholipid Syndrome Support Group
Antiphospholipid syndrome (or antiphospholipid antibody syndrome) is a disorder of coagulation which causes thrombosis in both arteries and veins, as well as recurrent miscarriage. It is due to the autoimmune production of antibodies against cell membrane constituents. A very rare form is the catastrophic antiphospholipid syndrome, in which there is rapid organ...
New blood thinner approved by FDA
Drugmaker Boehringer wins race with Pradaxa.
By Naomi Kresge and Catherine Larkin
Bloomberg News
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 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 to investors Wednesday.
Boehringer will start selling Pradaxa in the United States 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.
"We believe Pradaxa will be a blockbuster product," Hashad said, using industry parlance for medicines with annual sales of more than $1 billion.
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.
"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.
Read more: http://www.philly.com/inquirer/health_science/daily/20101021_New_blood_thinner_approved_by_FDA.html#ixzz130AsOaUD
Drugmaker Boehringer wins race with Pradaxa.
By Naomi Kresge and Catherine Larkin
Bloomberg News
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 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 to investors Wednesday.
Boehringer will start selling Pradaxa in the United States 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.
"We believe Pradaxa will be a blockbuster product," Hashad said, using industry parlance for medicines with annual sales of more than $1 billion.
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.
"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.
Read more: http://www.philly.com/inquirer/health_science/daily/20101021_New_blood_thinner_approved_by_FDA.html#ixzz130AsOaUD
As the article I wrote suggests, there still is no way to reverse the process like with Coumadin/Warfarin:
http://stoptheclot.org/News/article193.htm
It is anticipated that Bayer/Ortho-McNeils new oral anticoagulant will receive FDA approval shortly. Xarelto (Rivaroxaban) will be used initially for Orthopedic Surgery and AFib.
Other studies on both medications are taking place over in Europe currently. Treatment for DVT/PE and long term studies are being looked into by these continuing studies.
Regards,
Tom
I remember Dero saying he was in clinical trial for Dabigatran. and saying he felt great on it. I know not reversible but may be willing to switch for possibility of feeling better and take risk. Are you aware of others experiences with the drug? Pam
Denis (aka Dero) and I had talked about the trial he was on and though he felt a lot better when on Dabigatran then Coumadin, he evidentually decided to withdraw from the trial due to the fact that in a emergency case they could not reverse the bleeding.
Coumadin/Warfarin has been around for ages and we know it's side effects and risks. I feel these new oral anticoagulants will be a welcome alternative to our patient community, but, we have a long ways before we know the true long term side affects of any of these new medications.
As a life long Coumadin user, it will be a few years before I would decided to make a switch (need to see more long term data). However, for new patients who will be on it short term, the convienence of not having to get your INR checked daily, weekly, monthly will be an immense benefit.
I'll keep everyone posted on how things go now that these new medication are starting to hit the market her in the U.S.
Just an FYI. Lovenox (though much more expensive) can also be used without needing INR readings.
Pam,
I would really speak to a rheumatologist or your hemo about trying out plaquenil if you feel symptoms. It may really help you feel better because blood thinners alone do not take away alot of the symptoms we can get/have from the aps. I know I may sound like a broken record with the use of plaquenil and APS but I have been so sick from it and it helped me so much that I want to make sure others know there is another treatment other than just blood thinners used for APS.