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LONDON, UK / ACCESSWIRE / May 08, 2018 / If you want access to our free research report on Portola Pharma, Inc. (NASDAQ: PTLA), all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/?symbol=PTLA as the Company's latest news hit the wire. On May 03, 2018, the Company announced that the US Food and Drug Administration (FDA) has approved its lead candidate, 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. Register today and get access to over 1,000 Free Research Reports by joining our site below:
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Andexxa® is a recombinant protein specifically designed to bind to Factor Xa inhibitors and rapidly reverse their anticoagulant effect. Andexxa® is a modified form of the human Factor Xa molecule, an enzyme that helps blood clot. Andexxa® works by acting as a decoy for oral and injectable Factor Xa inhibitors, which target and bind to Factor Xa, and which allows them to exert their anticoagulant effect.
Importance of Andexxa®
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 (VTE). 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 US alone in 2016, there were approximately 117,000 hospital admissions attributable to Factor Xa inhibitor-related bleeding, and nearly 2,000 bleeding-related deaths are recorded per month as per the press release.
Andexxa® received both the FDA's Orphan Drug Designation and the Breakthrough Therapy Designation, 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.
Andexxa®'s approval was supported by the data from two Phase-3 ANNEXA studies (ANNEXA-R and ANNEXA-A) published in The New England Journal of Medicine, which evaluated the safety and efficacy of Andexxa® in reversing the anticoagulant activity of the Factor Xa inhibitors, rivaroxaban and apixaban, in healthy volunteers. The results demonstrated that Andexxa® rapidly and significantly reversed anti-Factor Xa activity, i.e. the anticoagulant mechanism of these medicines. The median decrease in anti-Factor Xa activity from baseline was 97% for rivaroxaban and 92% for apixaban.
The FDA, as part of its review and approval, also studied data from Portola's ongoing ANNEXA-4 single-arm, open-label study in patients with major bleeding. The data from 185 evaluable patients showed that Andexxa® rapidly and significantly reversed anti-Factor Xa activity when administered as a bolus, and sustained this reversal when followed by a 120-minute infusion. The median decrease from baseline was 90% for rivaroxaban and 93% for apixaban.
The post-marketing requirement for Andexxa® is a clinical trial that randomizes patients to receive either Andexxa® or usual care (the type of care the enrolling institution would provide in the absence of Andexxa®). This study is scheduled to be initiated in 2019, and to be reported in 2023.
Portola is forecasting to launch Andexxa® under an Early Supply Program with Generation 1 product in early June 2018. The broader commercial launch for the products is anticipated in early 2019 upon the FDA's approval of its Generation 2 manufacturing process.
The Marketing Authorization Application (MAA) for andexanet alfa is also under review by the European Medicines Agency. The Committee for Medicinal Products for Human Use (CHMP) communicated a positive trend vote on the MAA in February 2018. A formal opinion from the CHMP is expected by the end of 2018, and the European Commission is expected to issue a decision in early 2019.
Stock Performance Snapshot
May 07, 2018 - At Monday's closing bell, Portola Pharma's stock dropped 3.96%, ending the trading session at $40.76.
Volume traded for the day: 3.99 million shares, which was above the 3-month average volume of 1.42 million shares.
Stock performance in the last month – up 31.87%; and past twelve-month period – up 6.59%
After yesterday's close, Portola Pharma's market cap was at $2.19 billion.
The stock is part of the Healthcare sector, categorized under the Biotechnology industry. This sector was up 0.2% at the end of the session.
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