Eliquis Reversal Agent May Be Available Before Antidote for Xarelto or Pradaxa
As concerns continue about the risk of serious and potential life-threatening bleeding with Eliquis, Xarelto and Pradaxa, it appears that the makers of Eliquis may be close to introducing the first reversal agent for any of the drugs that are part of this new generation of anticoagulants.
Pradaxa, Xarelto and Eliquis have all been introduced in recent years as a replacement for warfarin, which has been the go-to-drug for prevention of strokes due to atrial fibrillation for decades, and the manufacturers are all competing to gain the market advantage in this lucrative sector.
The new medications have been promoted as superior alternatives to warfarin, since the manufacturers indicate they require less monitoring than warfarin. However, the drugs have been linked to thousands of reports involving uncontrollable bleeding, which doctors have been unable to stop due to the lack of any reversal agents for the medications.
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While all blood thinners carry a risk of bleeding events, warfarin has an effective antidote available, which doctors can use to quickly counteract the anticoagulant effects if bleeding problems develop among users.
The makers of Pradaxa, Xarelto and Eliquis have all been working to identify and obtain approval for a safe and effective reversal agent for their medication, which would likely provide the first to market with such an antidote a clear market advantage.
In a statement issued on October 1, Portola Pharmaceuticals indicated that a potential antidote for Eliquis has met both primary and secondary endpoints with high statistical significance in a phase 3 clinical trial, suggesting that they are close to confirming that tAndexanet Alfa can reliably stop the blood thinning effects of the drug in an emergency.
Bleeding Problems and Search for Antidote
Shortly after Boehringer Ingelheim introduced Pradaxa (dabigatran) as the first member of this new generation of drugs in October 2010, it became a “blockbuster” drug, generating over $1 billion in annual sales. However, it also quickly earned the dubious distinction as one of the medications most commonly associated with adverse event reports submitted to the FDA.
Amid reports involving users who suffered uncontrollable bleeding problems, Boehringer Ingelheim faced over 4,000 Pradaxa lawsuits alleging that inadequate warnings were provided about the lack of an available reversal agent for the medication, which the drug maker ultimately agreed to pay more than $650 million to settle.
Xarelto (rivaroxaban) was the second of this new generation to be approved by the market, introduced by Bayer and Johnson & Johnson in late 2011.
Amid concerns over the safety of Pradaxa, Xarelto quickly took over the top spot, with sales exceeding those of Pradaxa last year. However, there are now a growing number of Xarelto bleeding lawsuits being pursued on behalf of individuals nationwide, raising similar allegations that the drug makers never should have introduced the medication without an antidote to allow doctors to reverse bleeding events.
Eliquis (apixaban) was introduced by Pfizer and Bristol Myers-Squibb in 2012, as the third member of this new generation, and the drug makers have recently begun more aggressive marketing in hopes of toppling Xarelto. The drug makers have also obtained expanded approval for the anticoagulant, with the FDA approving use for the prevention and treatment of blood-clot related problems, such as deep vein thrombosis and pulmonary embolism.
Obtaining approval for an Eliquis reversal agent would give the drug a definitive edge among its competitors, potentially coming before antidotes being worked on by manufacturers of the other members of this new generation of drugs.
In February 2013, Bayer, Johnson & Johnson and Portola Pharmaceuticals announced that they planned to collaborate on the development of a Xarelto reveral agent, indicating that the companies will study the potential use of the recombinant protein PRT4445.
Earlier this year, the FDA granted “breakthrough status” to a potential Pradaxa antidote, idarucizumab, meaning that the drug would go to the front of the line for development and review in hopes of getting it to the market more rapidly.
The potential Pradaxa reversal agent is being tested at more than 200 sites in 30 countries around the world as part of clinical trials being called Re-Verse Ad, evaluating the effects of the antidote when used on patients taking Pradaxa who go to the emergency room due to uncontrollable bleeding and on users of the drug who require emergency surgery, where they are unable to stop the medication in advance of the procedure.
Detailed data on the use of andexanet alfa as a potential Eliquis antidote will be presented during a session at the American Heart Association’s 2014 Scientific Sessions, on Monday, November 17. The statement issued last week indicates that the reversal agent for Eliquis has the potential to be the first antidote approved for Factor Xa inhibitors, with the drug makers anticipating the filing of a Biologics License Application with the FDA for Accelerated Approval at the end of 2015.
PATRICIAFebruary 7, 2019 at 3:00 pm
I am a retired RN and have extensive clinical experience. The drug companies want to get rich at the cost of the consumer. BEFORE these drugs were placed on the market, the drug companies should have developed an antidote for each one. The FDA is at fault as well. Many have died because of the lack of the ability to reverse the action of the drugs mentioned above. I, personally, have had 2 de[Show More]I am a retired RN and have extensive clinical experience. The drug companies want to get rich at the cost of the consumer. BEFORE these drugs were placed on the market, the drug companies should have developed an antidote for each one. The FDA is at fault as well. Many have died because of the lack of the ability to reverse the action of the drugs mentioned above. I, personally, have had 2 dear friends die from an uncontrolled bleed related to Eliquis (apixaban). Both had a brain bleed after administration of this drug. God knows how many others have had the same with this drug as well as Xarelto and Pradaxa. If they had been given coumadin or heparin, their deaths would not have occurred. Vitamin K and protamine sulfate, respectively, would have reversed the working of the drugs just stated and the dosage could either have been adjusted based on INR, PT, and PTT findings. TOP this needless lose of life-- just to make the drug companies rich!!!!!! A simple enteric coated ASA, dose adjusted to 325 mg. would , and should, be given to prevent the development of a clot formation. This should be the FIRST line of defense in many cases. I call on the drug companies and the FDA to pull Eliquis, Xarelto, and Pradaxa from the market UNTIL there is a proven antidote to them. It is all about the 1 Billion dollar profit for the sale of Pradaxa in 2010. The over 4000 suits that amounted to 650 million dollars in settlement is a drop in the bucket for what the drug companies made. STOP THE MADNESS AND PULL THEM OFF THE MARKET UNTIL THE COMPANIES DEVELOP A PROVEN WAY TO REVERSE THE EFFECT OF THE DRUGS JUST MENTIONED. Thank you, Patricia, Retired Registered Nurse. Of note: I am on my way to see my best friend who lays in a coma due to a brain bleed after taking Eliquis. I pray to God this e-mail has some impact.
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