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FDA Assigns PDUFA Date to Portola Pharmaceuticals

For the large-scale Generation 2 manufacturing process for Andexxa

Portola Pharmaceuticals announced that the U.S. Food and Drug Administration has acknowledged receipt of the Company’s Prior Approval Supplement (PAS) filing for the large-scale Generation 2 manufacturing process for Andexxa® [coagulation factor Xa (recombinant), inactivated-zhzo]. 

 
The PAS has been assigned a Prescription Drug User Fee Act (PDUFA) date of December 31, 2018. If accepted and approved, the PAS will allow for the broad commercial launch of Andexxa in the United States.

Andexxa received both U.S. Orphan Drug and FDA Breakthrough Therapy designations, and was approved on May 3, 2018 under the FDA’s Accelerated Approval pathway. It is the first and only antidote indicated for patients treated with rivaroxaban and apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. 
 

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