|View printer-friendly version|
U.S. FDA Assigns PDUFA Date to Portola Pharmaceuticals’ Prior Approval Supplement for the Large-Scale Generation 2 Andexxa Process
Andexxa received both U.S. Orphan Drug and FDA Breakthrough Therapy designations, and was approved on
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.
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding timelines for regulatory review of our PAS and our ability to supply a broad commercial launch of Andexxa in
|Investor Contact:||Media Contact:|
|Cara Miller||Patrick Ryan|
|Portola Pharmaceuticals||Pure Communications|