PTLA: To FDA Prior Approval Supp Gen 2 Andexxa Process
Aug 31, 2018 13:57:42 GMT
tomsylver likes this
Post by icemandios on Aug 31, 2018 13:57:42 GMT
Portola Pharmaceuticals Submits Prior Approval Supplement to U.S. FDA for Large-Scale Generation 2 Andexxa Process
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 and head of research and development. “With the recent completion of three successful Generation 2 manufacturing campaigns, we have enough supply to stock more than 1,000 hospitals, and we look forward to working with regulatory authorities to achieve our goal of expanding patient access to this potentially life-saving medicine.”
Based on FDA timelines, the Company expects a final decision on the PAS in Q1 2019. In Europe, andexanet alfa received a positive trend vote from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency in February 2018. Pending the submission of additional data requested by the CHMP, a final CHMP opinion is expected in Q4 2018 with the potential for approval in Q1 2019.
Portola Pharmaceuticals is a commercial-stage biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutics that could significantly advance the fields of thrombosis and other hematologic diseases. The Company’s two FDA-approved medicines are Andexxa® [coagulation factor Xa (recombinant), inactivated-zhzo], the first and only antidote for patients treated with rivaroxaban and apixaban when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding, and Bevyxxa® (betrixaban), the first and only oral, once-daily Factor Xa inhibitor for the prevention of VTE in adult patients hospitalized for an acute medical illness. The company also is advancing cerdulatinib, a Syk/JAK inhibitor for the treatment of hematologic cancers.
