Portola Pharmaceuticals Inc. (NASDAQ: PTLA) saw its shares soar on Friday after announcing that it had received an approval from the U.S. Food and Drug Administration (FDA). Specifically, the agency approved Andexxa, 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 on post-marketing study results to demonstrate an improvement in hemostasis in patients.
The approval of Andexxa is supported by data from two Phase 3 ANNEXA studies. As described in the label, results demonstrated that Andexxa rapidly and significantly reversed the anticoagulant mechanism of rivaroxaban and apixaban.
Stuart J. Connolly, M.D., ANNEXA-4 Executive Committee chairman and professor in the Department of Medicine of the Faculty of Health Sciences at McMaster University in Hamilton, Ontario, commented:
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.
Bill Lis, CEO of Portola, added:
We are grateful to the patients who participated in our trials, our clinical trial collaborators, our employees and the FDA for their help in bringing this new drug to market for the benefit of patients with Factor Xa inhibitor-related bleeding. We are proud that Andexxa is a first-in-class medicine discovered in our labs. In addition to Bevyxxa, the first and only anticoagulant approved for extended VTE prevention in acute hospitalized medical patients, Andexxa is our second FDA-approved product with the potential to save lives and have a major impact on global public health. We remain committed to our scientific leadership in the fields of thrombosis and hematologic cancers.
Excluding Friday’s move, Portola had underperformed the broad markets, with its stock down about 15% in the past 52 weeks. In just 2018 alone, the stock was down 30%.
Shares of Portola were last seen up 20% at $40.51, with a consensus analyst price target of $53.50 and a 52-week range of $30.10 to $67.10.