Xarelto vs Eliquis - Pfizer/BMS win....

Discussion in 'Ortho-McNeil' started by Anonymous, Jun 23, 2011 at 3:06 PM.

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  1. Anonymous

    Anonymous Guest

    I would bet my bottom dollar that they screw this up big time! Have you looked at the managers! It makes me sick to see how unhealthy the majority are. Off label selling galore with no respect for anything but money. Very sad company I have to say
     

  2. Anonymous

    Anonymous Guest

    Bayer's new anti-clotting drug may not be superior to the old standby, warfarin, a new journal article suggests. But it is certainly just as good. And as co-author Gregory Zoppo told Reuters, "Non-inferiority is not a bad thing."

    The New England Journal of Medicine piece analyzed data from a comparative trial that had some folks scratching their heads: The trial concluded that Xarelto was 21% better at preventing stroke in atrial fibrillation patients than warfarin was. But that conclusion relied on an analysis that left out some patients who began the study. When those patients were included, the results put Xarelto more on par with warfarin.

    After taking a close look, the authors concluded the following: "I think we can say safely that [Xarelto] is not inferior to warfarin," Zoppo told the news service. "I don't think we can say it is superior." The NEJM editorial also put forward two caveats: One, the fact that new clot preventers such as Xarelto don't have antidotes that will quickly reverse their effects if serious bleeding occurs. Two, warfarin wasn't used optimally in the Xarelto study.

    Now, the question is how Xarelto--and its new rivals in the warfarin-alternative space, including Boehringer Ingelheim's Pradaxa--will fare against the older treatment. The newer drugs are much easier to take; warfarin is something of a dosing nightmare. That ease of use is "exciting," Zoppo said. But will everyone switch? "I think the answer is 'No.' Patients who are managed very well on warfarin should stay on it."

    And then there's the whole Xarelto vs. new competitors question. Pradaxa has some superior-to-warfarin data, efficacy-wise. And the yet-to-be-approved blood thinner from Pfizer and Bristol-Myers Squibb, Equilis, went one better in a recent trial, showing an edge over warfarin in stroke prevention and bleeding risk.
     
  3. Anonymous

    Anonymous Guest

    You can transfuse blood but you can't transfuse brain. When will you lab geeks figure out that? When a patient shows up in my ED, the last thing I am worried is about their anticoagulation. We can deal with that with FFP. More people die of strokes than bleeds.
     
  4. Anonymous

    Anonymous Guest

    GOOGLE this past week's Seeking Alpha article,

    J&J, Bayer muddied the waters on Xar
     
  5. Anonymous

    Anonymous Guest

    What is the status of this drug and the filling of the positions to sell it?
     
  6. Anonymous

    Anonymous Guest

    This is a bunch of shit. JNJ pharma cannot launch a product. When was the last successful launch? Levaquin 1997 .......UMMMMMM Oh Ultram ER , Regranex, Doribax, Nucynta(WHo cares about spelling) Invega!

    Blockbusters. At least that is what we were told.
     
  7. Anonymous

    Anonymous Guest

    The U.K.'s cost-effectiveness watchdog is carefully eyeing Boehringer Ingelheim's new clot-fighting drug. The National Institute for Health and Clinical Excellence says Pradaxa, a new alternative to the old bloodthinner warfarin, just isn't cost-effective--at least not using the data Boehringer has provided so far.

    NICE asked the German company for more information about Pradaxa, especially the cost effectiveness compared with warfarin. The agency thought Boehringer had overestimated the costs of monitoring patients on warfarin, thus overstating the cost-effectiveness of its alternative. NICE also wants "a more plausible set of assumptions" about Pradaxa's use in clinical practice, including better models for the type of atrial fibrillation patients found in the U.K.

    As InPharm reports, Pradaxa is estimated to cost £2.52 per day, or £919.80 per year ($1,520). Warfarin costs the NHS only £14.60 per year ($24). But the cost of warfarin alone doesn't cover everything; because of individual dosing differences, patients using warfarin have to be monitored. Boehringer has estimated that cost at £414.90, but NICE puts the average at £115.14.

    NICE did acknowledge that because it doesn't require monitoring, Pradaxa would be easier for patients to take. And the agency recognized the drug was superior to warfarin at reducing the risk of stroke, "an important development for patients with atrial fibrillation."
     
  8. Anonymous

    Anonymous Guest

    One anticipated risk of Boehringer Ingelheim's new blood thinner Pradaxa has led to an unexpected warning. Japanese regulators have asked the German company to notify doctors about potentially deadly bleeding in some Pradaxa patients, Reuters reports. Doctors need to be warned not only about the bleeding risks with the drug--marketed as Prazaxa in that country--but also that there's no antidote to counteract bleeding if it starts, the regulators said.

    With warfarin, the old drug Pradaxa seeks to replace, bleeding can be quickly treated with vitamin K. Neither Pradaxa nor any of the others in a new class of warfarin alternatives has a similar antidote. This new generation of drugs includes Xarelto, marketed by Bayer and Johnson & Johnson ($JNJ); Eliquis, the Bristol-Myers Squibb ($BMY)/Pfizer ($PFE) med that's awaiting U.S. approval; and Daiichi Sankyo's Lixiana.

    The lack of an antidote isn't a surprise. Nor is the bleeding risk with Pradaxa; it's clearly stated on the drug's label. The rate of serious bleeding with Pradaxa was 3.3% per year, Boehringer's fact sheet states, compared with 3.6% with warfarin; the rate of GI bleeding was higher with Pradaxa, however, at 1.6%, compared with 1.1% in warfarin patients. Most of the Japanese patients who developed problems had bleeding in their GI tracts. And just because the stats are listed doesn't mean that all doctors are up-to-date on the risks.

    Japanese officials suggest that patients older than 70 may need a lower dose of Pradaxa. Currently, the 110-mg dose is recommended for patients 80 and older. Boehringer says it's cooperating with the government on the warning, Reuters says, and that it's in the company's best interest to have the medicine prescribed within the recommended guidelines
     
  9. Anonymous

    Anonymous Guest

    Is warfarin's antidote for bleeding, vitamin K quick?
     
  10. Anonymous

    Anonymous Guest

    Best read this before predicting who has the best product.
    http://www.nejm.org/doi/full/10.1056/NEJMe1109748?query=featured_home&
     
  11. Anonymous

    Anonymous Guest

    NO KIDDING!

    Look out, warfarin-alternative market. Eliquis may be the last to hit, but it may hit the hardest. Some much-anticipated data came out at the European Society of Cardiology conference over the weekend, showing the Pfizer/Bristol-Myers Squibb drug beat standard warfarin therapy at reducing stroke or systemic embolism in patients with atrial fibrillation--with less risk of bleeding to boot. Plus, the risk of death from any cause was cut by 11%, a statistically significant result that's sure to make it into Eliquis' marketing campaigns.

    So, with this data from the Aristotle trial, Pfizer ($PFE) and BMS ($BMY) can tout their drug as the only new-generation anticoagulant to surpass warfarin in both efficacy and safety. And it's the first to show a statistically significant reduction in deaths, Forbes notes. Boehringer Ingelheim's Pradaxa proved better than warfarin at stroke-prevention, but the bleeding risk was about the same. And Xarelto from Bayer and Johnson & Johnson ($JNJ) basically matched the older drug at both. Pradaxa is FDA- and EMA-approved for stroke prevention, while Xarelto has a clot-prevention indication, and the partners expect to hear on its stroke-prevention app soon.

    Pfizer and BMS will certainly roll out a major marketing push, assuming Eliquis gets FDA approval to launch. But this data has experts talking up the drug already, even before the companies have asked the FDA for the indication. "It's a remarkable achievement," said Dr. Valentin Fuster, a past president of American and world heart associations, who was not involved with the trial, told the New York Times. "This is one of the most significant advances in cardiovascular medicine in the last [5] years, no question." And as the study leader tells Reuters, "It gives a lot of confidence when you see a drug that reduces mortality. That's another feather in the cap."

    Analysts are also hailing Eliquis, predicting it will easily take the lead position in this anticoagulant market, which is expected to top $10 billion. Leerink Swann's Seamus Fernandez figures Eliquis will top the new class of drugs with $4.2 billion in sales by 2017. Tony Butler of Barclays pegs peak sales at more than $5 billion, the Wall Street Journal reports. Mark Schoenebaum of ISI Group predicts Eliquis will get 60% of the market.
     
  12. Anonymous

    Anonymous Guest

  13. Anonymous

    Anonymous Guest

    Take a look at the patient populations. That's why you can't compare clinical trials to each other. DUH. A less severely acute patient population is going to look better vs any drug than a patient population with a higher level of acuity. Study design is also important. Hello?
     
  14. Anonymous

    Anonymous Guest

    QD vs BID anyone?
     
  15. Anonymous

    Anonymous Guest

    Study design is our prob
     
  16. Anonymous

    Anonymous Guest

    I totally agree with your comments. This market will be so over saturated with options and everything will come down to price. If patients do fine on warfarin, they will stay on it. People have no idea what pharmacy's power is now like...they will always choose the least expensive options no matter what they say...pharmacists are sleaze. This will not be a fun job.
     
  17. Anonymous

    Anonymous Guest

    FDA Reviewers Say J&J, Bayer Blood Thinner Should Be Rejected
    9/06/2011: 10:01AM

    Staff scientists at the Food and Drug Administration recommend that the agency reject Xarelto, a new blood thinner being developed by Bayer and Johnson & Johnson. The review is a huge blow to the drug giants. Analysts largely expected that Xarelto would generate peak sales of $1 billion or more.

    The reviewers also hinge their argument on a piece of FDA policy stating that “It is essential that a new therapy must be as effective as alternatives that are already approved for marketing when the disease to be treated is life-threatening or capable of causing irreversible morbidity (e.g. stroke or heart attack).” They argue that the fair comparison is not just warfarin, but warfarin used skillfully by doctors, and that Xarelto misses this bar. They also compare Xarelto unfavorably with the study that got Pradaxa approved as a treatment for atrial fibrillation.

    Nor is Xarelto, which has the generic name rivaroxaban, necessarily safer than warfarin, they say. “Nonetheless, if rivaroxaban is approved, patients taking it might be at greater risk of harm from stroke and/or bleeding than if they were treated with warfarin used skillfully,” they write. If doctors are in “great need” of a new pill to prevent strokes in atrial fibrillation patients, the reviewers say it might be reasonable to approve Xarelto as a second or third option. This is all very bad for J&J and Bayer.
     
  18. Anonymous

    Anonymous Guest

    Yikes!!!! Time to rearrange the deck chairs again!!!!
     
  19. Anonymous

    Anonymous Guest

    Hey cardiovascular sales force. Have your resume updated?
     
  20. Anonymous

    Anonymous Guest

    ANOTHER ARTICLE

    A bad review from Food and Drug Administration staff bodes ill for a Johnson & Johnson blood thinner.

    An FDA staff report released Tuesday recommends against approving Xarelto for preventing strokes in patients with a common irregular heart rhythm. The report says data from a late-stage study doesn't make clear whether Xarelto is as effective as widely used warfarin or how safe Xarelto is.

    Xarelto was approved in July for reducing the risk of deadly blood clots in patients getting knee and hip replacements, a small subgroup of the potential patient pool.

    Johnson & Johnson and partner Bayer Healthcare of Germany developed the drug.

    Next, a panel of outside advisers to the FDA is to review research on the drug Thursday.