Portola Pharmaceuticals Submits Prior Approval Supplement to U.S. FDA for Large-Scale Generation 2 Andexxa Process
PORTOLA PHARMACEUTICALS (PTLA)
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Source: GlobeNewswire
SOUTH SAN FRANCISCO, Calif., Aug. 31, 2018 (GLOBE NEWSWIRE) -- Portola Pharmaceuticals, Inc.® (Nasdaq:PTLA) today announced the submission of a prior approval supplement (PAS) to the U.S. Food and Drug Administration (FDA) for the large-scale Generation 2 manufacturing process for Andexxa® [coagulation factor Xa (recombinant), 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, 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. “We are pleased that patients are already benefitting from access to our limited supply Generation 1 product via an Early Supply Program,” said John Curnutte, M.D., Ph.D., interim co-president of Portola
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