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Portola Pharmaceuticals Andexanet alfa PDUFA

08/17/2016 - 00:00

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Andexanet alfa – an FDA-designated Breakthrough Therapy in development for patients treated with a direct or indirect Factor Xa inhibitor when reversal of anticoagulation is needed, such as in life-threatening or uncontrolled bleeding or for emergency surgery/urgent procedures; if approved, will be the first universal antidote for Factor Xa inhibitor anticoagulants:

Completed a BLA submission, which is awaiting acceptance for filing; the FDA assigned a PDUFA date of August 17, 2016 under an Accelerated Approval pathway.
Launch andexanet alfa in the second half of 2016 pending approval.
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Source: press release, 1/08/16. http://investors.portola.com/phoenix.zhtml?c=198136&p=irol-newsroomArtic...

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