Portola Pharmaceuticals Inc (NASDAQ:PTLA) reported that the U.S. FDA will extend its assessment of the Biologics License Application for AndexXa® by 90 days. The firm recently filed additional data sought by the agency for the current ANNEXA-4 trial as part of the continuing review procedure, which forms an amendment to the filing. Hence, the agency has established an extension to enable more time for an extensive assessment of the information offered and to work with the firm on post-marketing and labeling commitments. More recently, the FDA stated that the action date will change to May 4, 2018 from February 3, 2018.
Portola is advancing AndexXa as a universal reversal agent for people anticoagulated with an injectable or oral Factor Xa inhibitor who face a serious life-threatening or uncontrolled bleeding event or who need emergency or urgent surgery. The BLA intends preliminary nod of AndexXa for reversal of the anticoagulant impacts of rivaroxaban and apixaban in people experiencing life-threatening or uncontrolled bleeding.
Major bleeding such as gastrointestinal bleeding, intracranial hemorrhage and bleeding into other major organs, in subjects consuming Factor Xa inhibitor anticoagulants has been a considerable cause of hospital admissions, patient mortality and morbidity. In 2016, around 90,000 subjects in the U.S. cured with oral Factor Xa inhibitors were then admitted to the hospital following bleeding. Including subjects on the injectable Factor Xa inhibitor ‘enoxaparin’, it is projected that over 150,000 U.S. patients could gain from an antidote yearly.
Andexanet alfa is even under assessment by the European Commission of the EMA. A final call by the European Commission on the MAA for andexanet alfa is projected in 1H2018.
In the last trading session, the stock price of Portola Pharmaceuticals gained more than 3% to close the day at $48.68. The gains came at a share volume of 1.29 million compared to average share volume of 928,543.