Portola Plunges After Hint of Delay for FDA Approval of Factor Xa-inhibitor
Published: Mar 01, 2018 By Alex Keown
Shares of Portola Pharmaceuticals have fallen more than 27 percent in early trading after the company announced a delay of several months for possible regulatory approval of is Factor Xa-inhibitor antidote, AndexXa.
During a conference call to discuss the company’s year-end financial report, Portola leadership noted the U.S. Food and Drug Administration set a new action date of May 4 for its AndexXa Biologics License Application. However, that could change as the FDA may be hinting it needs the company to conduct another trial, according to Seeking Alpha. Company investors were certainly not pleased and began dumping the stock late Wednesday. Shares fell to a morning low of $30.30
During a conference call with investors and media, Portola Chief Executive Officer Bill Lis hinted that the regulatory agency is interested in additional data from the Phase III ANNEXA-4 study. If the FDA does seek additional information that could certainly delay potential approval for AndexXa. The FDA’s review date of AndexXa has already been pushed back by the agency. In late December Portola announced that the FDA extended the BLA review for AndexXa by 90 days. That happened after Portola submitted additional data requested by the agency for the ongoing ANNEXA-4 study.
AndexXa (andexanet alfa) is being developed as a universal reversal agent for patients who have been anticoagulated with an oral or injectable Factor Xa inhibitor who experience a serious uncontrolled or life-threatening bleeding event or who require urgent or emergency surgery. During the conference call on Wednesday Lis said in 2017 there were approximately 150,000 hospital admissions attributable to Factor Xa inhibitor-related bleeding. Of those there were about 2,000 deaths per month, Lis said, according to the transcript. Lis added that the U.S. Centers for Disease Control and Prevention estimates that Factor Xa bleeding-related deaths are among the top 15 causes of death in the United States.
Delays in FDA approval are certainly nothing new to Portola. Last year manufacturing delays forced the company to delay the launch of Bevyxxa (betrixaban). The company was finally given the green light in December to begin selling Bevyxxa, which had been approved by the FDA in June 2017. Bevyxxa, a factor Xa inhibitor, is a once-daily pill approved for hospital and extended duration prophylaxis of 35 to 42 days of venous thromboembolism (blood clots) in adult patients who have been hospitalized for an acute medical illness.
“We are pleased with the early indicators of the U.S. commercial launch of Bevyxxa, which began in January, and the potential to have a major public health impact on millions of patients in the U.S. and beyond,” Lis said in a statement on Wednesday.
If AndexXa is approved, Lis added that would position Portola with two first-in-class medicines in the field of thrombosis. Portola is also working on securing Marketing Authorization for both drugs in Europe.