![]() 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. Bleeding Problems and Search for Antidote 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. 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. Portola retains 100% worldwide decision-making and commercialisation rights to andexanet alfa.īayer HealthCare, Portola, Janssen Pharmaceuticals have a similar Phase III collaboration and expect to start a Phase III trial of andexanet alfa with Xarelto in the first half of 2014.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. Results from two Phase II proof-of concept trials showed that andexanet alfa immediately reversed the anti-Factor Xa activity of Eliquis and Xarelto (rivaroxaban) in healthy volunteers.Įarlier in 2014, Portola and BMS/Pfizer have entered into a Phase III collaboration that included an upfront payment and provides additional milestone payments that cover the clinical costs of the Phase III study. The company expects to report initial data from the first part of the study, in which andexanet alfa is administered as a bolus infusion, in the fourth quarter of this year, followed by bolus-plus-continuous infusion data from the second part of the trial in early 2015. In the trial, the company is using biomarker endpoints that have been agreed to with the FDA to support potential Accelerated Approval for the reversal of Factor Xa inhibitor anticoagulation. The trial participants will be followed for up to 43 days to assess safety. In the second part, around 32 healthy volunteers will be randomised in a 3:1 ratio to andexanet alfa administered as a 400mg IV bolus followed by a continuous infusion of 480mg at 4mg/min for 120 minutes or to placebo. In the first part of the trial, about 32 healthy volunteers will be given Eliquis 5mg twice daily and then randomised in a 3:1 ratio to andexanet alfa administered as a 400mg IV bolus or to placebo. "We are strategically focused on using biomarker and genetic approaches in our clinical development programmes to identify the patients who will most likely benefit from our products and potentially accelerate their approval," Curnutte said. Portola executive vice president of R&D John Curnutte said the start of the company’s first Phase III trial for andexanet alfa represents a significant milestone in the clinical development of this innovative drug to address the important unmet medical need for a Factor Xa inhibitor antidote. The randomised, double-blind, placebo-controlled Phase III trial will assess the efficacy of andexanet alfa in older healthy volunteers (ages 50-75 years) as showed by biomarker endpoints, including anti-Factor Xa levels, plasma free fraction of the anticoagulant and thrombin generation. ![]() "We are strategically focused on using biomarker and genetic approaches in our clinical development programmes to identify the patients who will most likely benefit from our products and potentially accelerate their approval." ![]()
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