SOUTH SAN FRANCISCO, Calif., Aug. 21, 2017 (GLOBE NEWSWIRE) -- Portola Pharmaceuticals Inc.® (Nasdaq:PTLA) today announced that data on betrixaban and andexanet alfa, as well as presentations on disease awareness and risk, will be presented at the European Society of Cardiology (ESC) Congress, which is taking place from August 26-30 in Barcelona, Spain.
Details regarding the presentations follow.
Poster Presentation Details:
- Poster Title: D-dimer concentration is associated with increased risk for VTE and greater absolute benefit of extended prophylaxis with betrixaban in acutely ill medical patients: insights from the APEX trial
- Poster #: P1551
- Poster Session: Session 2, Adverse outcome in patients with cardiometabolic disorders
- Presenter: Rim Halaby, M.D., Beth Israel Deaconess Medical Center, Boston
- Presentation Date and Time: August 27, 2017 from 8:30 a.m. - 12:30 p.m. UTC
- Poster Title: Extended duration betrixaban in acutely ill medical patients is associated with reduction in fatal or irreversible ischemic or bleeding events compared with standard dose enoxaparin: an APEX substudy
- Poster #: P1732
- Poster Session: Session 2, Coronary artery disease: from bench to bedside
- Presenter: Tarek Nafee, M.D., Beth Israel Deaconess Medical Center, Boston
- Presentation Date and Time: August 27, 2017 from 8:30 a.m. - 12:30 p.m. UTC
- Poster Title: Apixaban anticoagulation can be reversed using andexanet alfa in a polytrauma model
- Poster #: P4490
- Poster Session: Session 5, Cardiovascular care – Biology II
- Presenter: Pamela B. Conley, Ph.D., Portola Pharmaceuticals
- Presentation Date and Time: August 28, 2017 from 2:00 p.m. - 6:00 p.m. UTC
- Poster Title: N-Terminal pro-B–type Natriuretic Peptide (NT-proBNP) is associated with stroke among hospitalized medical patients: an APEX trial substudy
- Poster #: P4316
- Poster Session: Session 5, Stroke and Carotid disease
- Presenter: Gerald Chi, M.D., Beth Israel Deaconess Medical Center, Boston
- Presentation Date and Time: August 28, 2017 from 2:00 p.m. - 6:00 p.m. UTC
- Poster Title: Analysis of patient characteristics as covariates potentially affecting pharmacokinetics, efficacy, or safety of betrixaban in the APEX study
- Poster #: P5136
- Poster Session: Sessions 6, Best posters in prevention, interventions and outcomes
- Presenter: Janet Leeds, Ph.D., Portola Pharmaceuticals
- Presentation Date and Time: August 29, 2017 from 8:30 a.m. - 12:30 p.m. UTC
- Poster Title: Effect of extended-duration thromboprophylaxis on venous thromboembolism and major bleeding among acutely ill hospitalized medical patients: a bivariate analysis
- Poster #: P5599
- Poster Session: Session 6, Latest on STEMI
- Presenter: Gerald Chi, M.D., Beth Israel Deaconess Medical Center, Boston
- Presentation Date and Time: August 29, 2017 from 8:30 a.m. - 12:30 p.m. UTC
- Poster Title: History of venous thromboembolism is associated with higher risk for recurrent venous thromboembolism: insights from the APEX trial
- Poster #: P5600
- Poster Session: Session 6, Latest on STEMI
- Presenter: Megan K. Yee, Mercy Health, Grand Rapids
- Presentation Date and Time: August 29, 2017 from 8:30 a.m. - 12:30 p.m. UTC
- Poster Title: Andexanet alfa reduces betrixaban-induced blood loss in a rabbit liver laceration model of acute bleeding
- Poster #: P6208
- Poster Session: Session 7, Prevention general
- Presenter: Pamela B. Conley, Ph.D., Portola Pharmaceuticals
- Presentation Date and Time: August 29, 2017 from 2:00 p.m. - 6:00 p.m. UTC
About Portola Pharmaceuticals, Inc.
Portola Pharmaceuticals is a biopharmaceutical company developing product candidates that could significantly advance the fields of thrombosis and other hematologic diseases. The Company’s first medicine Bevyxxa® (betrixaban), an oral, once-daily Factor Xa inhibitor, was approved by the U.S. Food and Drug Administration in June 2017. The company is also working to advance two clinical programs for andexanet alfa, a recombinant protein designed to reverse the anticoagulant effect in patients treated with an oral or injectable Factor Xa inhibitor; and cerdulatinib, a SYK/JAK inhibitor in development to treat hematologic cancers. Portola's partnered program is focused on developing selective SYK inhibitors for inflammatory conditions. For more information, visit http://www.portola.com and follow the Company on Twitter @Portola_Pharma.
U.S. Important Safety Information for Bevyxxa (betrixaban)
INDICATION
BEVYXXA is indicated for the prophylaxis of venous thromboembolism (VTE) in adult patients hospitalized for an acute medical illness who are at risk for thromboembolic complications due to moderate or severe restricted mobility and other risk factors for VTE.
Limitations of Use:
The safety and effectiveness of BEVYXXA have not been established in patients with prosthetic heart valves because this population has not been studied.
WARNING: SPINAL/EPIDURAL HEMATOMA
EPIDURAL OR SPINAL HEMATOMAS MAY OCCUR IN PATIENTS TREATED WITH BETRIXABAN WHO ARE RECEIVING NEURAXIAL ANESTHESIA OR UNDERGOING SPINAL PUNCTURE. THE RISK OF THESE EVENTS MAY BE INCREASED BY THE USE OF IN‑DWELLING EPIDURAL CATHETERS OR THE CONCOMITANT USE OF MEDICAL PRODUCTS AFFECTING HEMOSTASIS. THESE HEMATOMAS MAY RESULT IN LONG -TERM OR PERMANENT PARALYSIS. CONSIDER THESE RISKS WHEN SCHEDULING PATIENTS FOR SPINAL PROCEDURES.
CONTRAINDICATIONS
Active pathological bleeding
Severe hypersensitivity reaction to BEVYXXA
WARNINGS AND PRECAUTIONS
- Risk of Bleeding
- BEVYXXA increases the risk of bleeding and can cause serious and potentially fatal bleeding.
- Concomitant use of drugs affecting hemostasis increases the risk of bleeding. These include aspirin and other antiplatelet agents, other anticoagulants, heparin, thrombolytic agents, selective serotonin reuptake inhibitors, serotonin norepinephrine reuptake inhibitors, and nonsteroidal anti-inflammatory drugs (NSAIDs).
- Advise patients of signs and symptoms of blood loss and to report them immediately or go to an emergency room.
- Promptly evaluate any signs or symptoms of blood loss and consider the need for blood replacement.
- Discontinue BEVYXXA in patients with active pathological bleeding.
- There is no established way to reverse the anticoagulant effect of Bevyxxa, which can be expected to persist for at least 72 hours after the last dose.
- Spinal/Epidural Anesthesia or Puncture
- When neuraxial anesthesia (spinal/epidural anesthesia) or spinal/epidural puncture is employed, patients treated with antithrombotic agents for prevention of thromboembolic complications are at risk of developing an epidural or spinal hematoma which can result in long-term or permanent paralysis.
- An epidural catheter should not be removed earlier than 72 hours after the last administration of BEVYXXA. The next BEVYXXA dose is not to be administered earlier than 5 hours after the removal of the catheter. If traumatic puncture occurs, delay the administration of BEVYXXA for 72 hours.
- Monitor patients frequently for signs and symptoms of neurological impairment (e.g., numbness or weakness of the legs, bowel, or bladder dysfunction). If neurological compromise is noted, urgent diagnosis and treatment is necessary.
- Use in Patients with Severe Renal Impairment
- Patients with severe renal impairment (CrCl ≥ 15 to < 30 mL/min computed by Cockcroft-Gault) taking BEVYXXA may have an increased risk of bleeding events
- Reduce dose of BEVYXXA, monitor patients closely, and promptly evaluate any signs or symptoms of blood loss in these patients.
- Use in Patients on Concomitant P-glycoprotein (P-gp) Inhibitors
- Patients on concomitant P-gp inhibitors with BEVYXXA may have an increased risk of bleeding.
- Reduce dose of BEVYXXA, monitor patients closely, and promptly evaluate any signs or symptoms of blood loss in these patients.
- Avoid use of BEVYXXA in patients with severe renal impairment receiving concomitant P‑gp inhibitors.
ADVERSE REACTIONS
- The most common adverse reactions with BEVYXXA were related to bleeding (> 5%).
USE IN SPECIFIC POPULATIONS
- Hepatic Impairment
- BEVYXXA has not been evaluated in patients with hepatic impairment, because these patients may have intrinsic coagulation abnormalities.
- BEVYXXA is not recommended in patients with hepatic impairment.
Please see full U.S. Prescribing Information and Medication Guide at Bevyxxa.com