Up to 83% clinical hemostasis, positive anticoagulant drug mid-term data
March 20, 2018 Source: WuXi PharmaTech
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];Recently, Portola Pharmaceuticals announced the mid-term data of its ongoing ANNEXA-4 clinical study at the American College of Cardiology (ACC) Scientific Annual Meeting. The data indicate that the experimental reversal agent AndexXa® (andexanet alfa) is associated with decreased activity of anti-factor Xa inhibitors and bleeding control.
In view of the effectiveness of factor Xa inhibitors in preventing embolic diseases such as stroke and pulmonary embolism, they are widely used and exhibit stable growth. However, the incidence of hospitalization and death associated with factor Xa inhibitor bleeding is also increasing. In the United States alone, the number of hospital admissions due to Xa-related bleeding in 2016 was approximately 117,000, with more than 2,000 deaths per month due to bleeding.
Andexanet alfa is an anticoagulant activity specifically developed by Portola Pharmaceuticals to reverse direct and indirect factor Xa inhibitors. Andexanet is a modified human protein that, once bound by Andexanet, does not bind to and inhibit the natural factor Xa and may therefore allow normal hemostasis to resume. Andexanet is being developed to address major and sometimes fatal bleeding problems associated with factor Xa inhibitors. The US FDA has granted andexanet a breakthrough therapy approval.
Led by Dr. Stuart Connolly, Chair of the ANNEXA-4 Research Executive Committee and Professor of the Department of Health Sciences at McMaster University, the researchers evaluated two common primary clinical endpoints for this first-in-class drug— - Reduce anti-factor Xa inhibitor activity and achieve clinical hemostasis within 12 hours after administration. The study enrolled a total of 228 patients from the United States, Canada, and Europe, of whom 132 were judged to have efficacy. All patients who participated in the study experienced acute major bleeding within 18 hours after taking four factor X inhibitors (apixaban apixaban, rivaroxaban rivaroxaban, edoxaban edoxaban, enoxaparin enoxaparin). They received a two-hour drug infusion after the andexanet injection, depending on the specific factor Xa inhibitor taken by the patient and the time since the last dose.
â–²Portola Pharmaceuticals R&D pipeline at a glance (Source: Portola Pharmaceuticals Official Website)
In patients taking rivaroxaban, anti-factor Xa inhibitor activity decreased by an average of 88%, patients taking apixaban decreased by 91%, and patients taking enoxaparin decreased by 75%. Few patients in the study were treated with edoxaban. 83% of patients achieved excellent or good clinical hemostasis. The safety of andexanet was evaluated in all 228 patients. At 30 days, 12% of patients died and 11% had thrombotic events.
Dr. Connolly said: "When you consider the high-risk characteristics of the ANNEXA-4 clinical study participants (including a large number of elderly patients with intracranial hemorrhage and anti-venous thromboembolism), and there is currently no FDA or EMA approved application. These data are particularly compelling in the reversal of these patients. Clinical efficacy and safety data continue to support AndexXa as an antidote to anticoagulant therapy for factor Xa-related bleeding."
We wish andexanet a smooth development and early approval to bring the gospel to patients with acute bleeding.
Reference materials:
[1] ANNEXA-4 Suggests Experimental Drug Controls Bleeding in Patients Taking Factor Xa Inhibitors
[2] Portola's official website
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