The fourth and final module of PMA (premarket approval) application for the United States Food and Drug Administration (FDA) approval of Toraymyxin® has been submitted according to a press release published on May 30th 2017.
A further data analysis of the EUPHRATES database identifies a population with significant mortality benefit when treated with Polymyxin B hemoperfusion therapy.
EUPHRATES, a randomized, blinded trial of patients in endotoxemic septic shock, comparing the use of Polymyxin B hemoperfusion therapy (Toraymyxin®) versus conventional therapy only, in the US and Canada, finished the enrollment phase in 2016.
Key Results of the EUPHRATES trial will be presented at the 35th Vicenza Course, Italy on June 14, 2017 and will be the subject of a manuscript currently in preparation for submission to a major peer-reviewed medical journal.