Andexanet Alfa: First Global Approval
Intravenous andexanet alfa [coagulation factor Xa (recombinant), inactivated-zhzo; Andexxa ® ] is a first-in-class recombinant modified factor Xa protein that has been developed by Portola Pharmaceuticals as a universal antidote to reverse anticoagulant effects of direct or indirect factor Xa inhibi...
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| Published in | Drugs (New York, N.Y.) Vol. 78; no. 10; pp. 1049 - 1055 |
|---|---|
| Main Author | |
| Format | Journal Article |
| Language | English |
| Published |
Cham
Springer International Publishing
01.07.2018
Springer Nature B.V |
| Subjects | |
| Online Access | Get full text |
| ISSN | 0012-6667 1179-1950 1179-1950 |
| DOI | 10.1007/s40265-018-0940-4 |
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| Abstract | Intravenous andexanet alfa [coagulation factor Xa (recombinant), inactivated-zhzo; Andexxa
®
] is a first-in-class recombinant modified factor Xa protein that has been developed by Portola Pharmaceuticals as a universal antidote to reverse anticoagulant effects of direct or indirect factor Xa inhibitors. In May 2018, andexanet alfa received its first global approval in the USA for use in patients treated with rivaroxaban and apixaban, when reversal of anticoagulant effects is required in life-threatening or uncontrolled bleeding. Intravenous andexanet alfa is under regulatory review in the EU and is undergoing clinical development in Japan. This article summarizes the milestones in the development of andexanet alfa leading to this first global approval for reversing anticoagulation of rivaroxaban and apixaban in adults. |
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| AbstractList | Intravenous andexanet alfa [coagulation factor Xa (recombinant), inactivated-zhzo; Andexxa
] is a first-in-class recombinant modified factor Xa protein that has been developed by Portola Pharmaceuticals as a universal antidote to reverse anticoagulant effects of direct or indirect factor Xa inhibitors. In May 2018, andexanet alfa received its first global approval in the USA for use in patients treated with rivaroxaban and apixaban, when reversal of anticoagulant effects is required in life-threatening or uncontrolled bleeding. Intravenous andexanet alfa is under regulatory review in the EU and is undergoing clinical development in Japan. This article summarizes the milestones in the development of andexanet alfa leading to this first global approval for reversing anticoagulation of rivaroxaban and apixaban in adults. Intravenous andexanet alfa [coagulation factor Xa (recombinant), inactivated-zhzo; Andexxa®] is a first-in-class recombinant modified factor Xa protein that has been developed by Portola Pharmaceuticals as a universal antidote to reverse anticoagulant effects of direct or indirect factor Xa inhibitors. In May 2018, andexanet alfa received its first global approval in the USA for use in patients treated with rivaroxaban and apixaban, when reversal of anticoagulant effects is required in life-threatening or uncontrolled bleeding. Intravenous andexanet alfa is under regulatory review in the EU and is undergoing clinical development in Japan. This article summarizes the milestones in the development of andexanet alfa leading to this first global approval for reversing anticoagulation of rivaroxaban and apixaban in adults. Intravenous andexanet alfa [coagulation factor Xa (recombinant), inactivated-zhzo; Andexxa ® ] is a first-in-class recombinant modified factor Xa protein that has been developed by Portola Pharmaceuticals as a universal antidote to reverse anticoagulant effects of direct or indirect factor Xa inhibitors. In May 2018, andexanet alfa received its first global approval in the USA for use in patients treated with rivaroxaban and apixaban, when reversal of anticoagulant effects is required in life-threatening or uncontrolled bleeding. Intravenous andexanet alfa is under regulatory review in the EU and is undergoing clinical development in Japan. This article summarizes the milestones in the development of andexanet alfa leading to this first global approval for reversing anticoagulation of rivaroxaban and apixaban in adults. Intravenous andexanet alfa [coagulation factor Xa (recombinant), inactivated-zhzo; Andexxa®] is a first-in-class recombinant modified factor Xa protein that has been developed by Portola Pharmaceuticals as a universal antidote to reverse anticoagulant effects of direct or indirect factor Xa inhibitors. In May 2018, andexanet alfa received its first global approval in the USA for use in patients treated with rivaroxaban and apixaban, when reversal of anticoagulant effects is required in life-threatening or uncontrolled bleeding. Intravenous andexanet alfa is under regulatory review in the EU and is undergoing clinical development in Japan. This article summarizes the milestones in the development of andexanet alfa leading to this first global approval for reversing anticoagulation of rivaroxaban and apixaban in adults.Intravenous andexanet alfa [coagulation factor Xa (recombinant), inactivated-zhzo; Andexxa®] is a first-in-class recombinant modified factor Xa protein that has been developed by Portola Pharmaceuticals as a universal antidote to reverse anticoagulant effects of direct or indirect factor Xa inhibitors. In May 2018, andexanet alfa received its first global approval in the USA for use in patients treated with rivaroxaban and apixaban, when reversal of anticoagulant effects is required in life-threatening or uncontrolled bleeding. Intravenous andexanet alfa is under regulatory review in the EU and is undergoing clinical development in Japan. This article summarizes the milestones in the development of andexanet alfa leading to this first global approval for reversing anticoagulation of rivaroxaban and apixaban in adults. |
| Author | Heo, Young-A |
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LuGPinePLeedsJMAndexanet alfa effectively reverses edoxaban anticoagulation effects and associated bleeding in a rabbit acute hemorrhage modelPLoS One.2018133e019512210.1371/journal.pone.01951222959022158740761:CAS:528:DC%2BC1cXhslentb%2FI Bristol-Myers Squibb, Pfizer. Bristol-Myers Squibb and Pfizer sign collaboration with Portola Pharmaceuticals to develop and commercialize investigational andexanet alfa in Japan [media release]. 1 Feb 2016. KaatzSBhansaliHGibbsJReversing factor Xa inhibitors—clinical utility of andexanet alfaJ Blood Med.2017814114910.2147/JBM.S121550289791725602457 Crowther M, Levy GG, Lu G, et al. A phase 2 randomized, double-blind, placebo-controlled trial demonstrating reversal of edoxaban-induced anticoagulation in healthy subjects by andexanet alfa (PRT064445), a universal antidote for factor Xa (FXa) inhibitors [abstract]. In: 56th annual meeting of the American Society of Hematology, ASH. 2014. LippiGSanchis-GomarFFavaloroEJAndexanet: effectively reversing anticoagulationTrends Pharmacol Sci.201637661361410.1016/j.tips.2016.03.0021:CAS:528:DC%2BC28Xks1ynuro%3D LuGDeGuzmanFRHollenbachSJA specific antidote for reversal of anticoagulation by direct and indirect inhibitors of coagulation factor XaNat Med.201319444645110.1038/nm.3102234557141:CAS:528:DC%2BC3sXjtlKnsbo%3D J Leeds (940_CR39) 2018; 46 940_CR18 940_CR19 G Lu (940_CR24) 2013; 19 G Lippi (940_CR8) 2016; 37 940_CR23 JE Ansell (940_CR4) 2016; 16 940_CR6 940_CR21 PB Conley (940_CR29) 2017; 27 940_CR22 940_CR28 940_CR1 940_CR26 S Kaatz (940_CR2) 2017; 8 940_CR20 PB Conely (940_CR30) 2017; 38 JH Levy (940_CR3) 2018; 15 M Crowther (940_CR33) 2014; 42 G Lu (940_CR25) 2018; 13 M Goldin (940_CR7) 2018; 25 TY Hu (940_CR5) 2016; 12 940_CR9 940_CR12 940_CR34 940_CR13 940_CR10 940_CR11 SJ Connolly (940_CR37) 2016; 375 940_CR16 TJ Milling Jr (940_CR27) 2016; 34 940_CR38 940_CR17 940_CR14 M Crowther (940_CR32) 2018; 46 940_CR15 DM Siegal (940_CR36) 2015; 373 D Siegal (940_CR35) 2017; 1 940_CR31 29296829 - Blood Adv. 2017 Sep 22;1(21):1827-1838 28979172 - J Blood Med. 2017 Sep 13;8:141-149 26559317 - N Engl J Med. 2015 Dec 17;373(25):2413-24 26872887 - Am J Cardiovasc Drugs. 2016 Jun;16(3):163-70 29590221 - PLoS One. 2018 Mar 28;13(3):e0195122 26937198 - Vasc Health Risk Manag. 2016 Feb 17;12:35-44 23455714 - Nat Med. 2013 Apr;19(4):446-51 27048885 - Trends Pharmacol Sci. 2016 Jun;37(6):413-414 29345686 - Nat Rev Cardiol. 2018 May;15(5):273-281 27573206 - N Engl J Med. 2016 Sep 22;375(12):1131-41 27697443 - Am J Emerg Med. 2016 Nov;34(11S):39-45 |
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| SubjectTerms | AdisInsight Report Adults Agreements Anticoagulants Bleeding Coagulation Coagulation factor Xa Hematology Internal Medicine Intravenous administration Manufacturing Medicine Medicine & Public Health Pharmaceuticals Pharmacology/Toxicology Pharmacotherapy Proteins Stroke Synthetic products |
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