Today is a big day for Boehringer Ingelheim. The FDA’s Cardiovascular and Renal Drugs Advisory Committee is reviewing its Pradaxa drug, which the German drugmaker hopes will win an endorsement for treating stroke prevention in patients with atrial fibrillation. That outcome appears highly likely, given that FDA reviewers took the unusual step of saying the med should be approved - albeit for only one of two doses sought by BI and without a superiority claim over Warfarin, the standard but difficult-to-take treatment (see the briefing documents here).
But what does this mean for the competition? You may recall that several other large drugmakers are racing to get their own bloodthinners into the hands of the nation's doctors - Bristol-Myers Squibb and Pfizer are developing apixaban, which scored well in a recent study (see here) with more to come next year, and Bayer and Johnson & Johnson have Xarelto; widely anticipated study results are due in November. At stake is market worth anywhere from $10 billion to $12 billion annually, depending upon whose estimate you believe. So what are the wags saying?
Even with an FDA recommendation, Boehringer may find that marketing Pradaxa against Xarelto will be challenging. Why? In a research note, Larry Biegelsen of Wachovia Securities points out that Bayer and J&J are seeking approval for only one dose of Xarelto. And so, "if the FDA advisory committee recommends approval of only the 150mg dose of Pradaxa," he writes, "the playing field will be more level for Xarelto because we believe Xarelto has a much greater chance of matching the efficacy and safety profile of the 150mg dose of Pradaxa than it does of matching the 110mg dose." Remember taht docs like flexibility when it comes to dosing. And the 110 mg does was not recommended by FDA staff.
He goes on to speculate that forthcoming Xarelto study results could pressure Pradaxa further, assuming that Xarelto demonstrates better efficacy and comparable safety to warfarin. Xarelto would have such advantages as more convenient dosing (once daily versus twice daily), better tolerability, and no myocardial infarction (MI) signal, which is an assumption on his part.
Meanwhile, Credit Suisse analyst Catherine Arnold wrote to investors that Boehringer's decision to submit an open label study is a gamble. The FDA reviewers, as noted already, declined to endorse a superiority claim, which means that Pradaxa will be at a disadvantage if rival meds "show superiority in a blinded trial and get that in their label." She also points out that, in Canada, where both Pradaxa and Xarelto are already available for acute settings following hip surgery, Xarelto "has proven to be the drug of choice based on clinical data," and has taken a 35 percent share of the market.
18 Comments
Does anybody else find it very odd that Bayer did the early to mid-development of Xarelto, partnered with J& J for later trials, and J & J ended up with the responsibility for the NDA?
Hi Lynn, Do you have more info about this you can share? :) Thanks denis
After the funny games with statins, Bayer has good reasons to stay away from your lovely little FDA (kind of economic warfare organisation, huuu?)
This drug will be a blockbuster for Boehringer. A product without blood monitoring and first in class. A Fib is huge
Hi Lynn, I have been in the drug development game for about ten years. It's not odd at all to be co-developing drugs especially, called mid development partnering. This happens all the time largely due to costs of clinical development. Happens in infrastructure development of roads and tunnels all the time. Cheers Shervo
I don't think co-development is odd at all. The issue is regulatory responsibility. I think it is odd to go half-way through development solo, and then go into a joint venture with J & J only in the US, and then have J & J responsible for the NDA while Bayer is responsible from a regulatory perspective for Xarelto for the rest of the world.
What needs to be done is a very thorough check on patients taking Pradaxa. I was prescribed Pradaxa after my pace maker indicated I had atrial fibrillation just before Christmas. I took my first pill at 8:00 that evening. At 10:00 I had an onslaught of chills and shakes so bad I wasn't sure if I would make it. I called 911 and they rushed me to the ER. They diddn't know if I had pnumonia, the flue, or what. The first two days I was in the hospital, I didn't get my Pradaxa. Some never heard of it. I noticed after a day or so, I was having trouble swallowing food and it even hurt to drink water at times. On Christmas eve they released me because my heart was stable? I had several appointments to see various doctors. Christmas day was the worst day of my life. I couldn't eat anything because it was excrutiating to swallow even a sip of water. The day after I went back to the Er. They took several tests, including a scope of my esophagus. They found I had some ring that constricted my esophagus at one point and perhaps a stomach ulcer. I never had any stomach problem as far back as I can remember and now I had all this. After my stress test Which turned out normal, I refused to take pradaxa and even turned down coumadin. I take a full aspirin a day in the form of 4 81mg baby aspirins. Half in the morning and half at night. I still have a slight restriction in my throat at times but no more pain. I have a great appetite and eat well. Pradaxa should be taken off the market until more study is done here in US by an independent lab. The drug is not doing what the drug company claims and the label on the drug should have a large warning about real stomack problems. While I was in the hospital after Christmas, My blood count went from 4 to 1 in two days and then back to 4 over night. The doctor said there was no record of anything that would cause that? I don't believe in coincidence and Pradaxa is a really bad drug. That may be only my opinion, but then again, I took it and have no motive except to warn others, DON"T TAKE THIS DRUG> PLUS AT $6 a pill it is rediculous. Very sincerely, James H. Sachse, Maj. USA Retired
I have been on Pradaxa for fourteen days, I have never had a reaction to any medication before but this medication has been very difficult. I first noticed uncontrollable chills, so bad that nothing would warm me up. Next came the worse abdominal pain, and bloating and indigestion that you can imagine. I decided as a nurse to give the drug a chance and take it for a few more days. My abdominal pain worsened, I began to feel extremely tired, the chills continued alternating with sweating. Lack of appetite and difficulty swallowing came next. Yesterday I called my cardiologist and began coumadin last night. I must continue the Pradaxa until the Thursday morning dose before being allowed to D/C it or increase my risk of stroke. The coumadin needs to get a proper level first. I am so sorry I ever tried this medication. coumadin will do just fine.
I took Pradaxa for almost 2 months because of atrial fibrillation but decided to stop this weekend due to very side effects, inclusing stomach pain, nausea, headaches, etc. I tried antiacids but it did not help. As soon as I stopped Pradaxa, I felt much better.
I took Pradaxa for almost 2 months because of atrial fibrillation but decided to stop this weekend due to very bad side effects, inclusing stomach pain, nausea, headaches, etc. I tried antiacids but it did not help. As soon as I stopped Pradaxa, I felt much better.
My Grandmother 90, was taken off metropolol and given Sotalol and Pradaxa after a short talk and a 10 min EKG, He never said it is new, not proven, unsure as to actual side effects, etc, She is over 90 has had kidney issues and ablation to her heart years ago, Well the 8th she got her 1st doses and by the 15th was in the ER unable to walk almost, nausea, diahrehea, in the ER they said she was low on blood 4 pints and a pint of plasma, maybe 2 plasma as she says she had another after I left the 1st night, 4 days intensive care, 4 days in telemetry, The hospitalist said he never saw this drug yet, she was the 1st, and also the 1st he saw in effect overdosed!! and no reversal was available and it may never stop! She is out now, but so weak I must be with her almost 24-7 now! do not take this drug!!!
what happened with your afib? Did you treat it another way?
I have been taking Pradaxa for two months now and no problems or side effects.
I have been taking pradaxa for nearly four months. Have never felt so bad. Headaches chills lump in throat trouble swallowing food and even drinking water. I'm off to dr and ask him to put me back on Coumadin. I hate needles and also gained weight but at least o felt well.
I have been taking Pradaxa since January 2011 with no side effects. My cardiologist said I was a perfect candidate for the drug. I have had afib for nine years and take tikosyn and had taken coumadin. I am now 70. The considerations were the cost of Pradaxa, and that there was no antidote in case of a car accident with bleeding injuries. Not having monthly blood checks with my rolling veins was a major offset and bruising from minor bumps has almost been totally eliminated.
I would apreciate some advice concerning Pradaxa taken with Effient and 81 mg aspirin.
I am 67 yo, female, staying in an RV, alone in Florida. I live in SC, just here for the winter. About 10 days ago I experienced what I knew to be signs of an impending heart attack or some cardiac incident. Stupidly I drove myself to the ER and, thankfully, I made it.
I was admitted with A Fib, heart rate 160, out of sinus rythym. Given Cardizem, settled down and all was well........I thought. Next day the world started turning black..no pain..but I knew, no doubt, I was having a real MI. Heart rate 200, they had me coughing, straining, everything. I went back to normal sinus rythym.
Doctor came in to tell me we had issues..I had had a slight MI, left side of the heart. He said I needed a cardiac cath. I would have preferred another hospital and another doctor but I was, I thought, where I was supposed to be. I could have been in the Alaskan wilderness, so I was lucky. I had the cath, blockage 90% right side of the heart and a stent put in.
I was discharged with PRADAXA 75 mg, one cap 2x a day and Effient 10 mg, 1x a day AND an 81mg aspirin.
I went to the pharmacy to pick up the scripts and the pharmacist asked if I were sure that these were to be taken together. I knew nothing of any dangers; no one had said anything to me, this was an emergency and, even though I was afraid of the doctor and the hospital I was grateful that they had saved my life.
The pharmacist called my doctor. I honestly could see that she was attempting to compose herself. She did NOT want me taking these meds and she wanted to tell me. She lectured me on bleeding dangers, wrote it all over the papers, and also wrote TAKING THESE TOGETHER CHECK INR. I though that was why they gave me them; so INR check wasn't necessary.
I start taking the drugs tomorrow. I am terrifed after reading what can happen. I have RA, diabetes, Sick Sinus Syndrome, Cooley's Anemia, Fatty Liver, protein in my urine, Systemic lyme and when I sign off I will remember more.
I do NOT feel well after having the stent placed, I thought I would. I have symptoms I had prior to the stent. I do not wish to feel as horrible as I have read described on this forum.
Advice? Suggestions? I would realy appreciate some. Thank You. Lorraine
PS I have some regular Warfarin that my internist gave me and I could take that until I get home in a few days.
Lump in throat cased by capsule getting stuck (possibly a hiatal hernia) in throat and opening. It is not recommended but emptying capsule into mouth and washing down with water will solve the lump in the throat issue. Worked for me.