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Portola's Supplementary Approval Paves Way For Belated Bevyxxa Launch

 
• By Emily Hayes

Bevyxxa finally set to become the fifth new oral anticoagulant on the US market, but in a unique, niche indication of acute medical illness.

FDA approved background, 3D rendering, blue street sign

Portola Pharmaceuticals Inc. is gearing up for the belated launch of the novel oral anticoagulant Bevyxxa (betrixaban) in early January, following FDA approval of its manufacturing process on Dec. 19.

The agency approved the Factor Xa inhibitor in June for prophylaxis (35 to 42 days) of venous thromboembolism in patients hospitalized for an acute medical illness and at risk for thromboembolic complications. (Also see "Portola's Bevyxxa Poised To Capture Niche Novel Anticoagulant Market" - Scrip, 26 June, 2017

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