Portola Pharmaceuticals Announces New APEX Study Sub-Analyses Data on Betrixaban to be Presented at the America Heart Association (AHA) Scientific Sessions 2017
Portola Pharmaceuticals Announces New APEX Study Sub-Analyses Data on Betrixaban to be Presented at the America Heart Association (AHA) Scientific Sessions 2017
[November 07, 2017]
Portola Pharmaceuticals Announces New APEX Study Sub-Analyses Data on Betrixaban to be Presented at the America Heart Association (AHA) Scientific Sessions 2017
SOUTH SAN FRANCISCO, Calif., Nov. 07, 2017 (GLOBE NEWSWIRE) -- Portola Pharmaceuticals Inc.® (Nasdaq:PTLA) today announced that results of new sub-analyses of the APEX Study of betrixaban will be presented in oral and poster sessions at the upcoming American Heart Association (AHA) Scientific Sessions 2017, which is taking place from November 11-15 in Anaheim, California.
Details regarding the presentations follow.
Oral Presentations:
Presentation Title: Extended-Duration Betrixaban Reduces The Risk of Venous Thromboembolism-Related Rehospitalization Among Acutely Ill Hospitalized Medical Patients: An APEX Trial Substudy
Session Number: VA.AOS.829
Session Title: Best in Show Vascular Disease and Thrombosis Science
Presenter: Gerald Chi, M.D., PERFUSE Study Group, Beth Israel Deaconess Medical Center, Boston
Presentation Date and Time: November 14, 2017 from 2:00 p.m. – 3:15 p.m. PT
Session Title: Emerging Science and Discovery in Vascular Disease and Thrombosis
Presenter: Gerald Chi, M.D., PERFUSE Study Group, Beth Israel Deaconess Medical Center, Boston
Presentation Date and Time: November 14, 2017 from 3:45 p.m. – 5:00 p.m. PT
Presentation Number: 387
Location: 210C (Main Building)
Poster Presentation:
Poster Title: Betrixaban Reduces Not Only The Presence of Thrombus But Also Extent of Thrombus: An APEX Trial Substudy
Session Number: VA.APS.07
Session Title: Horizons in Venous Thromboembolism: Emerging Science in Pathophysiology, Treatment, and Prevention
Presenter: Gerald Chi, M.D., PERFUSE Study Group, Beth Israel Deaconess Medical Center, Boston
Presentation Date and Time: November 12, 2017 from 3:15 p.m. – 4:30 p.m. PT
Presentation Number: S5173
Location: Science and Technology Hall-Clinical Science III Section
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 mor 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
Forward-Looking Statements
This announcement contains forward-looking statements, including statements relating to Portola Pharmaceuticals’ expectations regarding the completion, timing and size of the proposed public offering. These statements are subject to significant risks and uncertainties and actual results could differ materially from those projected. Portola Pharmaceuticals cautions investors not to place undue reliance on the forward-looking statements contained in this release. These risks and uncertainties include, without limitation, risks and uncertainties related to market conditions and satisfaction of customary closing conditions related to the public offering. There can be no assurance that Portola Pharmaceuticals will be able to complete the public offering on the anticipated terms, or at all. Risks and uncertainties relating to Portola Pharmaceuticals and its business can be found in the “Risk Factors” section of Portola Pharmaceuticals’ Quarterly Report on Form 10-Q for the second quarter of 2017, which was filed on August 9, 2017, and in the prospectus supplement related to the proposed offering filed with the SEC. Portola Pharmaceuticals undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events or changes in Portola Pharmaceuticals’ expectations.
