Portola Pharmaceuticals announces Andexxa PAS submission to FDA

Portola Pharmaceuticals announced the submission of a prior approval supplement, or PAS, to the FDA for the large-scale generation 2 manufacturing process for Andexxa, inactivated-zhzo. If approved, the PAS will allow for 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 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. Based on FDA timelines, the company expects a final decision on the PAS in Q1 2019.
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