SOUTH SAN FRANCISCO, Calif.,
March 16, 2020 /PRNewswire/ --
Portola Pharmaceuticals, Inc.® (Nasdaq: PTLA) today
announced new data reinforcing the value of
Andexxa® [coagulation factor Xa (recombinant),
inactivated-zhzo], the first and only FDA-approved reversal agent
for the Factor Xa inhibitors rivaroxaban or apixaban. The data
demonstrated that Andexxa was associated with a lower rate of
in-hospital and 30-day mortality in patients with life-threatening
Factor Xa inhibitor-related bleeds compared with other treatment
options. This included lower mortality across multiple bleed types
including intracranial hemorrhage (ICH), gastrointestinal bleeding
(GI) and bleeding due to trauma, when compared to 4-factor
prothrombin complex concentrate (4F-PCC) therapy, which is approved
only for the reversal of warfarin.
"The number of patients experiencing serious, life-threatening
bleeding associated with Factor Xa inhibitors continues to increase
as their use grows rapidly in the U.S. and Europe," said Craig I.
Coleman, Pharm.D., University of
Connecticut, School of Pharmacy and Hartford Hospital
Evidence-Based Practice Center. "For the first time, we are
presenting real-world data that demonstrates that for these
patients Andexxa was associated with the lowest in-hospital
mortality across a variety of other treatment options."
Key results, originally scheduled to be presented at the
American College of Cardiology's Annual Scientific Session together
with the World Congress of Cardiology (ACC.20/WCC),*
demonstrated:
- Case matched data showed 30-day mortality was 14.6% with
Andexxa versus 34.1% with 4F-PCC across all bleed types, a relative
risk reduction of 57.2% (abstract #1213-209 / 209).
-
- Among the subgroup of patients who experienced ICH, 30-day
mortality was lower in the Andexxa group (15.3% vs. 48.9%), and the
relative risk reduction was greater (68.7%).
- In a separate analysis, real-world data showed in-hospital
mortality was 4% with Andexxa and 10% with 4F-PCC across all bleed
types (abstract #1055-05).
-
- Among the subset of patients who experienced ICH, the
in-hospital mortality was 9% with Andexxa versus 25% with
4F-PCC.
"This important comparison of Andexxa to 4F-PCC demonstrated
lower 30-day mortality with the use of Andexxa in patients with
Factor Xa inhibitor-related bleeding across multiple types of
bleeds," said Alexander T. Cohen,
MBBS, M.Sc., M.D., a consultant physician and epidemiologist at
Guy's and St Thomas' Hospitals NHS Foundation Trust. "I believe
these findings strengthen the case for the use of Andexxa versus
4F-PCC in these patients, and further establish Andexxa as the
standard of care for a broad group of patients on rivaroxaban or
apixaban who are experiencing life-threatening or uncontrolled
bleeding."
The new findings are based on the results of multiple data sets.
One analysis provided an indirect comparison of Andexxa and 4F-PCC
using case-matched data from two large studies of Factor Xa
inhibitor patients – the 322-patient ANNEXA-4 study and ORANGE, a
three-year prospective registry of patients admitted to UK
hospitals with major bleeding who received 4F-PCC. The second was a
real-world study of electronic medical records from 45 U.S.
hospitals used to identify patients admitted for bleeding related
to Factor Xa inhibitors (1,075 bleeds) and managed with either
Andexxa or 4F-PCC.
"These findings contribute to the growing body of evidence
supporting the potential life-saving benefits of Andexxa, the first
and only FDA-approved reversal agent for the Factor Xa inhibitors
rivaroxaban or apixaban," said Rajiv
Patni, M.D., Portola's
chief medical officer. "We have a robust strategy to generate and
present additional data over the next year, which we believe will
enhance our ability to educate key hospital stakeholders that by
choosing Andexxa, they can prioritize both the clinical value it
provides and responsible budgeting in their patient care."
In addition, new health economics and outcomes research (HEOR)
data reveal the burden of bleeding requiring hospitalization on
patients and healthcare systems. Hospitalization for ICH bleeds was
associated with the highest in-patient mortality, the greatest need
for further out-of-home care and the longest length of stay in the
hospital compared to other bleed types (abstract #1320-233 / 233).
The high thrombotic risk profile (e.g., those with atrial
fibrillation [AF] or deep vein thrombosis/pulmonary embolism
[DVT/PE]) of included patients suggests that many could have been
receiving oral anticoagulants.
Data accepted by ACC.20/WCC* includes:
- Management of Oral Factor Xa Inhibitor Bleeding-Related
Hospitalizations with Andexanet Alfa or 4-Factor Prothrombin
Complex Concentrate (abstract #1055-05)
Presenter: Craig I.
Coleman, Pharm.D., University of
Connecticut, School of Pharmacy/Hartford Hospital
Evidence-Based Practice Center
Original Format: Moderated Poster Presentation
Session: Updates in VTE and Stroke
- 30 Day Mortality Following Andexanet Alfa in ANNEXA-4
Compared with Prothrombin Complex Concentrate (PCC) Therapy in The
ORANGE Study for Life-Threatening Non-Vitamin K Oral Anticoagulant
(NOAC) Related Bleeding (abstract #1213-209 /
209)
Presenter: Alexander T. Cohen, MBBS, M.Sc., M.D., Guy's
and St Thomas' Hospitals NHS Foundation Trust
Original Format: Poster Presentation
Session: Vascular Medicine: Non Coronary Arterial Disease
3
- Outcomes Associated with Bleeding-Related Hospitalizations
in Patients at High Thrombotic Risk Findings from the Nationwide
Readmission Database (abstract #1320-233 / 233)
Presenter: Craig I.
Coleman, Pharm.D., University of
Connecticut, School of Pharmacy/Hartford Hospital
Evidence-Based Practice Center
Original Format: Poster Presentation
Session: Arrhythmias and Clinical EP: Supraventricular
/ Ventricular Arrhythmias 5
*Note: The ACC.20/WCC meeting in Chicago has been cancelled due to public
health concerns and will now be held virtually. Abstracts
originally accepted for the meeting are available at:
https://www.abstractsonline.com/pp8/#!/8992.
About ANDEXXA
ANDEXXA (coagulation factor Xa
(recombinant), inactivated-zhzo) is a recombinant modified human
factor Xa (FXa) protein indicated for patients treated with
rivaroxaban or apixaban, when reversal of anticoagulation is needed
due to life-threatening or uncontrolled bleeding.
Important Safety Information
The most frequently reported adverse reactions in clinical
trials in healthy subjects with Andexxa were mild or moderate
infusion-related reactions comprising symptoms such as flushing and
feeling hot (very common), and cough, dysgeusia, and dyspnea
(common). Amongst bleeding patients, commonly reported side effects
were ischemic stroke and pyrexia, with uncommon reported side
effects of cerebral infarction, cerebrovascular accident, transient
ischemic attack, acute myocardial infarction, cardiac arrest,
myocardial infarction, deep vein thrombosis, iliac artery
occlusion, pulmonary embolism.
Please refer to full Prescribing Information for more
information, including Boxed Warning, at www.Andexxa.com.
About Portola Pharmaceuticals, Inc.
Portola
Pharmaceuticals is a global, commercial-stage biopharmaceutical
company focused on the discovery, development and commercialization
of novel therapeutics that could significantly advance the fields
of thrombosis and other hematologic conditions. The Company's first
two commercialized products are Andexxa® [coagulation
factor Xa (recombinant), inactivated-zhzo], marketed in
Europe as Ondexxya®
(andexanet alfa), and Bevyxxa® (betrixaban). The company
also is advancing cerdulatinib, a SYK/JAK inhibitor being developed
for the treatment of hematologic cancers. Founded in 2003 in
South San Francisco, California,
Portola has operations in
the United States and Europe.
Forward-Looking Statements
Statements contained in
this press release regarding matters that are not historical facts
are "forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995. Because such statements
are subject to risks and uncertainties, actual results may differ
materially from those expressed or implied by such forward-looking
statements. Such statements include, but are not limited to,
statements regarding Portola's
development plans, and the potential benefits of Andexxa. Risks
that contribute to the uncertain nature of the forward-looking
statements include: the risk that physicians, patients and payers
may not see the benefits of utilizing Andexxa for the indications
for which it is approved; our ability to continue to manufacture
our products and to expand approved manufacturing facilities; the
possibility of unfavorable results from additional clinical trials
or other studies involving Andexxa; our ability to grow our
commercial operations in the EU and generate product revenue within
projected timelines and budget; the risk that we may not obtain
additional regulatory approvals necessary to expand approved
indications for Andexxa; our expectation that we will incur losses
for the foreseeable future and will need additional funds to
finance our operations; the accuracy of our estimates regarding
expenses and capital requirements; our ability to successfully
build a hospital-based sales force and commercial infrastructure;
our ability to obtain and maintain intellectual property protection
for our product candidates; our ability to retain key scientific or
management personnel and general market conditions. These and other
risks and uncertainties are described more fully in our most recent
filings with the Securities and Exchange Commission, including our
most recent annual report on Form 10-K. All forward-looking
statements contained in this press release speak only as of the
date on which they were made. We undertake no obligation to update
such statements to reflect events that occur or circumstances that
exist after the date on which they were made.
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SOURCE Portola Pharmaceuticals, Inc.®