Portola: FDA extends review period for PAS for Bevyxxa
Portola Pharmaceuticals announced that the U.S. Food and Drug Administration has extended the review period for the company's Prior Approval Supplement for Bevyxxa to allow the agency time to review the entire submission. The FDA informed the company today that it will respond to the PAS request to change the current manufacturing release specification within the standard 60-day extension period. No additional information was requested at this time. The new action date is January 30, 2018. "As we communicated earlier this month, we've made good progress with the FDA and have established an agreement in principle on the change to our product release specification that would allow for the release and distribution of current product inventory. We also noted that the agency might need additional time to review our submission," said Bill Lis, chief executive officer of Portola. "While the FDA completes its review, the momentum within the medical community is building. We continue our commercial and medical education activities in anticipation of a potential launch by February 2018, and remain committed to getting Bevyxxa to patients who may benefit from this important and potentially life-saving new therapy."