Portola Pharmaceuticals Inc (NASDAQ:PTLA) closed Friday’s trading session at $28.54 after a noteworthy uptick probably fueled by the announcement of its ANNEXA-4 Study results for Andexxa.
Andexxa is the company’s Factor Xa inhibitor antidote, and the recently announced results are from its Phase 3b/4 clinical trial known as ANNEXA-4. The trial evaluated the safety and efficacy of the treatment in patients experiencing a lot of bleeding when consuming Factor Xa inhibitor. The company presented the data through a late stage presentation during the International Stroke Conference 2019 held on February 8. The data was also published by The New England Journal of Medicine (NEJM).
The research team involved in the ANNEXA-4 clinical trial for Andexxa evaluated 352 patients. Data collected from 249 of those patients was aimed at determining the treatment’s hemostatic efficacy. The data collected from all the 352 patients demonstrated the treatment’s ability to cause a remarkable reversal when anti-Factor Xa’s activity quickly.
The results of the study demonstrated consistent and positive changes
The reversal was observed when patients the treatment was administered as a bolus, and the reversal was sustained if the dose was followed by a 120-minute infusion. Anti-Factor Xa activity measures anticoagulant activity in enoxaparin, edoxaban, rivaroxaban, and apixaban. The above four are the anticoagulants that the researchers studied in the ANNEXA-4 clinical trial.
“We now also have new data demonstrating no observed thrombotic events after resumption of oral anticoagulation,” stated ANNEXA-4 Executive Committee member Truman J. Milling Jr.
Milling also noted that the consistency observed in Andexxa’s safety and efficacy data despite age, dose or type of bleed confirms the treatment’s ability to combat bleeds caused by Factor Xa inhibitors. The consistency demonstrated by Andexxa as well as its positive and strong response from international medical societies represent great news for the company. The treatment could benefit thousands of people that experience life-threatening bleeding after using apixaban or rivaroxaban.
The U.S Food and Drug Administration (FDA) gave Andexxa an Orphan Drug designation and a Breakthrough Therapy destination in May 2018. It also happens to be the only drug that has been approved as an antidote for patients treated with apixaban and rivaroxaban.