European CHMP Adopts Positive Opinion on Ondexxya™ (andexanet alfa) Portola Pharmaceuticals’ Factor Xa Inhibitor Reversal...
March 01 2019 - 7:38AM
Portola Pharmaceuticals, Inc.® (Nasdaq: PTLA) today announced that
the Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA) has adopted a positive opinion on
the marketing authorization application (MAA) for Ondexxya™
(andexanet alfa). The Committee has recommended that the European
Commission (EC) grant Ondexxya conditional approval for the
reversal of the anticoagulant effects of the Factor Xa inhibitors
apixaban or rivaroxaban in patients experiencing uncontrolled or
life-threatening bleeding.
The MAA will now be reviewed by the EC,
which has the authority to approve medicines for use in the 28
countries of the European Union, Norway,
Liechtenstein and Iceland. If approved, Ondexxya would be
the first and only specific reversal agent available in Europe to
address life-threatening bleeding associated with the use of
apixaban or rivaroxaban. The EC is expected to issue a decision in
early May 2019.
"Today's positive CHMP opinion represents a
significant step forward in patient care and in the ability of
clinicians to address life-threatening bleeds associated with the
use of Factor Xa inhibitors," said Jan Beyer-Westendorf, M.D., Head
of the Thrombosis Research Unit, Department of Medicine I; Division
Hematology, University Hospital Dresden, Germany. "Given the
number of patients currently taking Factor Xa inhibitors and the
anticipated growth of their utilization in Europe, the medical
community has been eagerly awaiting the availability of an antidote
that, in case of emergencies, can rapidly reverse the
anticoagulating effects of rivaroxaban or apixaban. The European
Society of Cardiology has already recognized the potential role of
andexanet alfa, and we look forward to the potential approval and
availability of this important medicine."
The MAA submission is based on data from two
Phase 3 ANNEXA studies that evaluated the safety and efficacy of
Ondexxya in reversing the anticoagulant activity of the Factor Xa
inhibitors rivaroxaban or apixaban in healthy subjects. Results of
the ANNEXA studies were published in 2015 in The New England
Journal of Medicine. The MAA also included adjudicated efficacy and
safety data from bleeding patients enrolled in ANNEXA-4, the
Company’s Phase 3b/4 study, the full results of which were
published in The New England Journal of Medicine in February
2019.
“Today’s opinion is an important milestone for
Portola and for patients in Europe, where the use of Factor Xa
inhibitors is higher than in the U.S.,” said Scott Garland,
Portola’s president and chief executive officer. “Given the
consistency of the ANNEXA-4 data and the significant unmet need for
a Factor Xa inhibitor reversal agent, we believe Ondexxya
has the potential to benefit thousands of patients and we look
forward to the opportunity to expand patient access in Europe this
year.”
For a conditional approval, Portola is required
to provide 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.
Andexanet alfa 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].
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 regulatory pathway for potential approval
of Ondexxya in the EU. Risks that contribute to the uncertain
nature of the forward-looking statements include: the risk that the
EMA may not approve Ondexxya in the currently anticipated timelines
or at all, and that any marketing approvals or reimbursement
limitations may have significant limitations on its use; the risk
that physicians, patients and payers may not see the benefits of
utilizing Andexxa or Bevyxxa 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 quarterly report on
Form 10-Q. 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:Cara
Miller
Portola Pharmaceuticals
IR@portola.com |
Media Contact:Julie NormartPure
Communicationsjnormart@purecommunications.com |
Portola Pharmaceuticals (NASDAQ:PTLA)
Historical Stock Chart
From Aug 2024 to Sep 2024
Portola Pharmaceuticals (NASDAQ:PTLA)
Historical Stock Chart
From Sep 2023 to Sep 2024