Portola Pharmaceuticals, Inc. (NASDAQ: PTLA) rose in Friday trading following news that the U.S. Food and Drug Administration has approved Andexxa for the reversal of factor Xa inhibitors.
Andexxa is the first and only antidote indicated for patients treated with rivaroxaban and apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.
Andexxa received both U.S. Orphan Drug and FDA Breakthrough Therapy designations and was approved under the FDA’s Accelerated Approval pathway based on the change from baseline in anti-Factor Xa activity in healthy volunteers. Continued approval for this indication may be contingent upon post-marketing study results to demonstrate an improvement in hemostasis in patients.
Said Stuart J. Connolly, professor at Hamilton, Ontario’s McMaster University, "Today’s approval represents a significant step forward in patient care and one that the medical community has been eagerly anticipating.
"Andexxa’s rapid reversal of the anticoagulating effects of rivaroxaban and apixaban will help clinicians treat life-threatening bleeds, where every minute counts."
The use of Factor Xa inhibitors is rapidly growing because of their efficacy and safety profile compared to enoxaparin and warfarin in preventing and treating thromboembolic conditions such as stroke, pulmonary embolism and venous thromboembolism.
This growth has come with a related increase in the incidence of hospital admissions and deaths related to bleeding, the major complication of anticoagulation. In the U.S. alone in 2016, there were approximately 117,000 hospital admissions attributable to Factor Xa inhibitor-related bleeding and nearly 2,000 bleeding-related deaths per month.
Shares in Portola skyrocketed $8.16, or 24.2%, to $41.94
