A new perspective from the U.S. Food and Drug Administration (FDA) published in the New England Journal of Medicine(1) states that the agency has not changed its recommendations regarding Pradaxa® (dabigatran etexilate), following the November 2012 Mini-Sentinel evaluations.(2)
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FDA perspective published in the New England Journal of Medicine reinforces safety of Pradaxa® (dabigatran etexilate)
Clot-fighter Eliquis won a thumbs up for stroke prevention–courtesy of Pfizer The U.K.'s cost-effectiveness watchdogs must really like Eliquis . The new blood thinner from Pfizer ( $PFE ) and Bristol-Myers Squibb ( $BMY ) won a thumbs-up for stroke prevention, just three months after winning approval for that use in the E.U. It's a nice push forward for the drug, which will be vying for market share against Bayer 's Xarelto and Boehringer Ingelheim 's Pradaxa . The National Institute for Health and Clinical Excellence issued final draft guidance backing Eliquis to prevent strokes in patients with atrial fibrillation , an abnormal heart rhythm. The drug was already approved to prevent and treat venous thromboembolism, but the stroke-prevention use is the real prize. It's a much larger market. Eliquis may be third to reach the market after Pradaxa and Xarelto, but it's been hotly anticipated as clearly superior to warfarin . NICE's Carole Longson said the agency's appraisal committee concluded that Eliquis was “more clinically effective than warfarin” at reducing stroke and systemic embolism, and that the drug “resulted in fewer bleeding events than warfarin,” including dangerous bleeding in the skull. The old standard treatment comes with a host of dosage-tweaking rules, plus interactions with alcohol and food, so it is difficult for patients to take and doctors to manage. Longson cited those difficulties in announcing the Eliquis approval: “The Appraisal Committee heard from patient experts that warfarin can have a greater impact on a person's quality of life than atrial fibrillation itself,” she said. The advent of Eliquis will put Boehringer and Bayer on their toes. The first-to-market Pradaxa now comes with safety warnings, including a caution against its use in people with kidney problems. Worries about bleeding risks have put some doctors off its use, despite the fact that it's seen as no more dangerous than warfarin, because the new-generation anticoagulants don't have quick-acting antidotes as the old drug does. Xarelto won't escape the Eliquis launch unscathed, either, analysts have said. – get the release from NICE – read the PharmaTimes story Special Report: Eliquis – Blockbuster buzz: 15 top therapies in late-stage development Related Articles: FDA approves Pfizer, BMS warfarin alternative Pfizer, BMS win blockbuster FDA approval for Eliquis Japan OKs warfarin alternative Eliquis from BMS, Pfizer Pfizer and Bristol's Eliquis marches closer to FDA decision ?
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Clot-fighter Eliquis wins speedy new backing from NICE
Bristol-Myers Squibb ( $BMY ) and Pfizer ( $PFE ), which have yet to get their blood thinner Eliquis approved in the U.S., have gotten a third regulatory nod elsewhere. Japan approved the warfarin alternative today for the prevention of ischemic stroke and systemic embolism in patients with nonvalvular atrial fibrillation. Eliquis is already approved in the European Union and Canada, but the FDA has twice turned it away, saying it needed more time and more information. It is now set to rule by March 17, an approval that would clear the path for it to reach its blockbuster potential.? There is data that suggests Eliquis could be the best of the alternatives to side-effect-heavy warfarin, but two others have beat it to the U.S., giving them a leg up. Those are Johnson & Johnson's ( $JNJ ) Xarelto and Boehringer Ingelheim 's Pradaxa . Pradaxa, which has already surpassed the billion-dollar sales mark, has run into some issues of late over concerns about its bleeding risks. An Australian government agency last week said that given new data, it had decided to reconsider whether to recommend that the government cover its cost. That came despite a recent announcement by the FDA that a further review of data found the bleeding risk for Pradaxa to be no greater than for warfarin.? – here's the press? release – get more from the Associated Press Related Articles: Australia reconsidering paying for Pradaxa FDA backs Pradaxa safety as docs lament lack of antidote Pradaxa hits blockbuster mark, swelling Boehringer sales
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Japan OKs warfarin alternative Eliquis from BMS, Pfizer
Pradaxa is under fire again. Pradaxa , the warfarin alternative from? Boehringer Ingelheim , is again under fire only weeks after the FDA released information that the blood thinner was at least as safe as the drug it seeks to supplant. Authorities in Australia are reconsidering their recommendation for its use there, and the FDA just sent out a new medical alert warning against using the blood thinner on patients with mechanical heart valves. The Pharmaceutical Benefits Advisory Committee (PBAC) in Australia says that based on new data, it is reconsidering its recommendation that the government cover the cost of the drug, PharmaTimes reports. The notice to the government is in a report on the use of anticoagulant therapy. The report acknowledges that there are health and financial benefits to the drug but says some real-world data suggests that it is being used by a different age group of patients and at different doses than the clinical data presented to the PBAC when it approved it last year. That has led the group to say more study may be needed. The agency has invited Boehringer Ingelheim to submit new data. The company has data it can submit. It recently released results of a longer-term study that showed that over 4.3 years the efficacy and safety of the blockbuster drug did not wane. There also are the FDA findings released in early November. The agency sought to quell growing concerns from physicians about using Pradaxa, a drug that already has hit blockbuster status because it doesn't come with the nasty side effects associated with warfarin. But it also doesn't have an antidote for bleeding like warfarin does, so some doctors have publicly discussed frustrations. The FDA sorted through thousands of? records to determine that despite an onslaught of adverse-event reports–and hundreds of deaths–rates of gastrointestinal bleeding and intracranial hemorrhage were no higher in Pradaxa patients than in those using the older drug. Still, the FDA this week warned doctors against using Pradaxa in patients with mechanical heart valves, pointing out that a study was stopped because they “were more likely to experience strokes, heart attacks and blood clots forming on the mechanical heart valves than were users of the anticoagulant warfarin.” – read the PharmaTimes ? story Related Articles: FDA backs Pradaxa safety as docs lament lack of antidote Long-term study reinforces safety record of blockbuster Pradaxa
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Australia reconsidering paying for Pradaxa
Pfizer and Bristol-Myers Squibb finally have the chance to give their new blood thinner a real boost. European regulators approved Eliquis to prevent stroke in patients with atrial fibrillation , giving the drug access to a much larger market. It's the drug's first approval for that use worldwide–and its first big step toward blockbuster status. While Eliquis won't exactly mint money off this new approval, it could spin some serious gold for Pfizer ( $PFE ) and Bristol-Myers ( $BMY ). Millions of patients in Europe have atrial fibrillation, and studies have shown that the prevalence of AF is rising. So, whereas Eliquis brought in just $1 million for Bristol-Myers Squibb during the third quarter, based on its approval for clot prevention in certain surgery patients, the drug really could take off in the AF market. Indeed, analysts figure it can hit up to $5 billion in peak sales if it wins approval in the U.S. And that makes Eliquis a major new product for Pfizer and Bristol-Myers Squibb, which share sales and profits equally. Both companies have lost patent protection on their previous best-sellers, Lipitor and Plavix . Sales of those meds have plummeted, putting a big drag on overall revenues. While Eliquis won't completely fill the gaps left by those now-generic megablockbusters, it could be a big help. Eliquis will compete with warfarin, the standard-and-generic treatment it's designed to replace, and with two other warfarin alternatives. Boehringer Ingelheim 's Pradaxa has the biggest head start; it won European approval for stroke prevention in AF patients last August. Bayer 's Xarelto secured the same indication in December. But Eliquis has an edge over both of its head-to-head competitors, and you can bet that Pfizer and Bristol-Myers will use it. “Eliquis is the only oral anticoagulant that has demonstrated superior risk reduction versus warfarin in the three important outcomes of stroke and systemic embolism, major bleeding, and all-cause mortality,” the companies said in announcing the approval. Pfizer CEO Ian Read touted its “differentiated profile.” Sales materials and reps will be beating that drum repeatedly. In one major trial, Eliquis beat warfarin at preventing strokes, and the Eliquis arm saw fewer bleeding problems. Xarelto only matched warfarin on safety and efficacy. Pradaxa outperformed warfarin in its own supporting trials, but FDA questioned the quality of that data–the study wasn't totally blind–and didn't allow Boehringer to claim superiority to warfarin on its label. Plus, since Pradaxa's introduction, Boehringer has had to strengthen warnings against its use in kidney patients, after FDA and EMA reviewed reports of hundreds of deaths and even more cases of serious bleeding. Both agencies have continued to back the drug–and pointed out that Pradaxa has been prescribed to millions of patients–but some doctors have grown leery. Unlike warfarin, neither Pradaxa nor any of its warfarin-alternative rivals, has an antidote to stop serious bleeding once it starts. (Boehringer is looking for one.) Eliquis is still waiting for FDA approval, after a series of delays. In June, the agency surprised analysts–and the companies, no doubt–by putting off approval again, probably till spring 2013. – get the companies' press release – see the Reuters news Special Report: Eliquis – Blockbuster buzz: 15 top therapies in late-stage development Related Articles: Pfizer, Bristol-Myers win landmark European approval for Eliquis Xarelto, Pradaxa find reprieve in Eliquis delay Pfizer/BMS data poses threat to BI's Pradaxa
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Armed with EU stroke approval, Pfizer, BMS talk up Eliquis’ edge over rivals
Rack up another set of new uses for Bayer 's Xarelto . The anticoagulant won European approval to treat and prevent pulmonary embolism and to prevent deep vein thrombosis. It's the first warfarin -alternative drug to win these indications, giving it an edge over its rival Pradaxa . The European clearance follows a similar expansion of Xarelto's market in the U.S., where it's marketed by Bayer's development partner Johnson & Johnson ( $JNJ ). Early this month, FDA approved Xarelto to treat PE and DVT, and to prevent a recurrence after initial treatment. Both the EMA and FDA have cleared the drug to prevent clots in certain surgery patients and to reduce the risk of stroke in patients with atrial fibrillation. It's all part of Bayer's plan to pump Xarelto into a major blockbuster. In a recent R&D update, CEO Marijn Dekkers touted his estimates for Xarelto once again, saying Bayer could realize $2.5 billion in annual sales from the drug. The company also announced plans for a major outcomes study, which will pair Xarelto with aspirin. The aim is to determine whether the regimen will prevent stroke, heart attack and death in patients with coronary and peripheral artery disease. It hasn't been all smooth sailing for the drug, however. Earlier this year, the FDA dealt a big disappointment to J&J and Bayer's hopes; it declined to approve it to prevent heart attacks and other cardiovascular events in patients with acute coronary syndrome. J&J has submitted new information to the agency, expecting a response early next year. – see the release from Bayer – read the RTT News story – get more from PM Live Related Articles: J&J's Xarelto nabs new clot-prevention use Bayer gambling $4B R&D budget on Xarelto, top blockbuster hopefuls FDA panel draws blood in Xarelto's bid for new use J&J, Bayer try to answer FDA concerns on Xarelto Pradaxa, Xarelto gain reprieve as FDA delays Eliquis decision
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Europe adds new uses to Xarelto’s marketing arsenal
RIDGEFIELD, Conn., Nov. 2, 2012 /PRNewswire/ — The U.S. Food and Drug Administration (FDA) today announced the results of a Mini-Sentinel assessment that indicates bleeding rates associated with new use of Pradaxa? (dabigatran etexilate…
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FDA Mini-Sentinel Assessment Reinforces Safety Data of Pradaxa (dabigatran etexilate mesylate)
The FDA's balancing act is no easy feat. In fact, it just might be impossible. As soon as the agency gets congressional direction to revamp and speed up approvals, experts in other quarters conclude that approvals are coming too fast. In an article published by the Journal of the American Medical Association , drug-safety advocates point to a few recently approved drugs– Boehringer Ingelheim 's Pradaxa , AstraZeneca's ( $AZN ) Caprelsa, and Novartis' ( $NVS ) Gilenya –as examples of an FDA rush to judgment. The JAMA writers–including Thomas J. Moore, whose CenterWatch publication issues drug-safety information based on FDA adverse event reports–said “significant safety questions” were unanswered when the three meds got the agency's blessing. They question Caprelsa's safety and efficacy, citing toxicity issues and a lack of overall survival benefit. AZ told The Wall Street Journal that its trials found a 65% decrease in the risk of progression-free survival. And then there's Pradaxa. Since its launch in 2010, the Boehringer blood thinner has been linked to thousands of adverse event reports and hundreds of cases of fatal bleeding. The FDA is reviewing case reports; after their own review, European regulators asked for label changes, but said the drug's benefits are still worth the risk for appropriate patients. Finally, there's Gilenya. As the JAMA article points out, FDA required multiple post-marketing studies when the multiple sclerosis drug was approved. Heart-rate problems flagged early on have surfaced in the “real world,” but patient advocates say the drug is still a viable treatment option. The JAMA writers themselves said that Gilenya proved better than an existing drug at preventing MS relapses. “I would hardly say the Gilenya experience constitutes going too fast,” the National Multiple Sclerosis Society's Timothy Coetzee told the WSJ . The FDA's director for drug evaluation and review, Janet Woodcock , points out that for certain diseases, people want treatment options, even if those options could be risky. “I'd like to stress that where there are unmet medical needs, the public has told us they are willing to accept greater risks,” Woodcock told the newspaper. “The cancer community in particular says we haven't used accelerated approvals enough.” – see the WSJ story Related Articles: Heart docs skeptical of new-generation clotbusters EMA supports Pradaxa but seeks sharper warnings for bleeding Novartis reports patient taking Gilenya developed rare brain disease Watchdog says FDA should consider restricting Gilenya Gene study finds tumor-cell flaw possibly vulnerable to Pfizer, AZ cancer meds
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JAMA says FDA jumped the gun on Gilenya, Pradaxa
Boehringer Ingelheim has announced that the combined treatment experience with Pradaxa® has crossed one million patient-years(1) in the prevention of thromboembolic events in patients after surgery and in patients with non-valvular atrial fibrillation (AF), providing the greatest body of clinical experience among all novel oral anticoagulants.
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Clinical experience with Pradaxa® crosses one million patient-years of treatment
So much for a speedy review of Eliquis , the new anticoagulant from Bristol-Myers Squibb ( $BMY ) and Pfizer ( $PFE ). After putting the drug on its fast track in November, the FDA first put off its decision date by three months, and now has issued a complete response letter looking for more data-crunching (but no new studies). Best expectation for an approval? Next spring. That may be a setback for Bristol-Myers and Pfizer, but for Eliquis' rivals, it's a breather. Boehringer Ingelheim 's Pradaxa and Johnson & Johnson's ( $JNJ ) Xarelto now have the warfarin -alternatives field to themeslves for the near term. And given the data on Eliquis–which suggests it could beat both drugs on efficacy and safety–that reprieve must be a welcome one. And all the more welcome because it's unexpected. “All of this (delay) is surprising given the widespread perception that Eliquis is a best-in-class product relative to already-approved novel oral anticoagulants Pradaxa and Xarelto, ” Sanford Bernstein analyst Tim Anderson said in a note to investors. It's particularly helpful for Xarelto. The J&J drug, developed in partnership with Bayer , just lost out on a new indication in patients with acute coronary syndrome, which includes those who've had a heart attack or suffer from chest pain. That could have been a lucrative market, one that Pradaxa and Eliquis couldn't compete in directly, unlikely as they were to win a similar indication. So, the Eliquis delay gives J&J more time to grab market share in atrial fibrillation patients. Approved?in 2010, a year ahead of Xarelto, Pradaxa has the lead in those patients, at least for now. Reports of bleeding-related deaths among Pradaxa users, including one highly publicized case of a patient who died after striking her head in a fall, have some doctors wary of using the drug. Statistically, the numbers aren't out of the realm predicted by clinical trials, Boehringer maintains, and millions of patients have used Pradaxa. But unlike warfarin, the old standard, there's no quick antidote to Pradaxa, or for any of its new rivals, for that matter. – see the release from Bristol-Myers and Pfizer – check out the Reuters news Related Articles: FDA rejects blockbuster Eliquis bid, asks Pfizer, BMS for trial clarification FDA delivers Xarelto bad news to J&J, Bayer EMA supports Pradaxa but seeks sharper warnings for bleeding
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Xarelto, Pradaxa find reprieve in Eliquis delay
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