European Commission Grants Conditional Marketing Authorization for Portola Pharmaceuticals’ Ondexxya™ (andexanet alfa), t...
April 26 2019 - 2:00PM
– Major Advance in the Treatment of European
Factor Xa Inhibitor Patients Hospitalizedwith Life-Threatening
Bleeding –
Portola Pharmaceuticals, Inc.® (Nasdaq: PTLA) today announced that
the European Commission (EC) has granted conditional Marketing
Authorization for Ondexxya™ (andexanet alfa). Ondexxya is the first
and only antidote approved in Europe for adult patients treated
with the Factor Xa inhibitor apixaban or rivaroxaban when reversal
of anticoagulation is needed due to life-threatening or
uncontrolled bleeding.
“The medical community has been eagerly anticipating the
approval of Ondexxya and the ability to rapidly reverse the
anticoagulating effects of rivaroxaban or apixaban,” said Jan
Beyer-Westendorf, M.D., Head of the Thrombosis Research Unit,
Department of Medicine I; Division Hematology, University Hospital
Dresden, Germany. “As the number of European patients prescribed
these Factor Xa inhibitors continues to increase, so too does the
incidence of hospital admissions related to bleeding. The approval
of Ondexxya represents a significant step forward in the treatment
of these patients, who previously had no approved treatment
option.”
The conditional approval of Ondexxya was based on data from two
Phase 3 ANNEXA studies (ANNEXA-R and ANNEXA-A) that evaluated the
safety and efficacy of Ondexxya in reversing the anticoagulant
activity of the Factor Xa inhibitors rivaroxaban or apixaban in
healthy subjects, and data from the Phase 3b/4 ANNEXA-4 study that
evaluated efficacy and safety data from 352 bleeding patients.
Results from all three studies were published in The New England
Journal of Medicine – ANNEXA-R and ANNEXA-A in 2015, and ANNEXA-4
in February 2019.
“The unmet need for a reversal agent in Europe is significant,
as the number of patients taking a Factor Xa inhibitor is nearly
double that of the U.S. and continuing to grow at a significant
rate. To help ensure we reach as many patients as quickly as
possible, our initial launch efforts will be focused on a select
group of countries where Factor Xa use is among the highest,” said
Scott Garland, Portola’s president and chief executive officer. “We
are very proud that, in just one year, we have achieved both U.S.
and European approval of this potentially life-saving medicine and
look forward to continuing to expand patient access in these
countries and beyond.”
The EC grants conditional authorizations to medicines that
fulfill a medical need and show a potential benefit to public
health, and for which additional data are required by the EC. As
part of the conditional approval, Portola will provide the final
study reports for both the ANNEXA-4 trial and the randomized
controlled clinical trial requested by the U.S. Food and
Drug Administration (FDA), as well as additional
pharmacokinetic data.
Ondexxya was approved by the FDA in May 2018 and is marketed by
Portola in the U.S. under the trade name Andexxa® [coagulation
factor Xa (recombinant), inactivated-zhzo].
Important Safety InformationThe most frequently
reported adverse reactions in clinical trials in healthy subjects
with Ondexxya were mild or moderate infusion-related reactions
comprising symptoms such as flushing and feeling hot (very common),
and cough, dysgeusia, and dyspnoea (common). Amongst bleeding
patients, commonly reported side effects were ischaemic stroke and
pyrexia, with uncommonly reported side effects of cerebral
infarction, cerebrovascular accident, transient ischaemic attack,
acute myocardial infarction, cardiac arrest, myocardial infarction,
deep vein thrombosis, iliac artery occlusion, pulmonary
embolism.
Please refer to full SmPC for further information on side
effects reported with Ondexxya.
The U.S. full prescribing information for Andexxa is available
at www.andexxa.com
About Portola Pharmaceuticals,
Inc.Portola Pharmaceuticals is a 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 diseases.
The Company’s two FDA-approved medicines are Andexxa®
[coagulation factor Xa (recombinant), inactivated-zhzo], the first
and only antidote for patients treated with rivaroxaban or apixaban
when reversal of anticoagulation is needed due to life-threatening
or uncontrolled bleeding, and Bevyxxa® (betrixaban), the first
and only oral, once-daily Factor Xa inhibitor for the prevention of
VTE in adult patients hospitalized for an acute medical illness.
The company also is advancing cerdulatinib, a Syk/JAK inhibitor for
the treatment of hematologic cancers.
Forward-Looking StatementsStatements 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 the anticipated launch timing and
strategy for Ondexxya in Europe and potential treatment benefits of
Ondexxya. 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 Ondexxya
for the indications which they are approved; our ability to
continue to manufacture our products and to expand approved
manufacturing facilities; the possibility of unfavorable results
from additional clinical trials involving Andexxa; the risk that
Portola 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; and our ability to
retain key scientific or management personnel. 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.
Investor Contact: |
Media Contact: |
Cara Miller |
Julie Normart |
Portola Pharmaceuticals |
Pure Communications |
ir@portola.com |
jnormart@purecommunications.com |
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