CHMP Extends Review Period for Portola Pharmaceuticals’ Ondexxya™ (andexanet alfa)
11 Décembre 2018 - 1:00PM
Portola Pharmaceuticals, Inc.® (Nasdaq: PTLA) today announced that
the Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA) has extended the review period for
the Company’s marketing authorization application (MAA) for
Ondexxya™ (andexanet alfa), and cancelled the Oral Explanation
scheduled for Wednesday, December 12, 2018. An opinion is now
expected by February 28, 2019.
The CHMP informed Portola yesterday that it will
provide a list of outstanding questions related to the data package
the Company submitted for Ondexxya last quarter, which will require
additional responses from the Company. The preliminary timetable
provided to the Company by the CHMP sets a deadline of January 29,
2019 for responses to the questions followed by a 30-day assessment
period for the CHMP to review the Company’s responses.
Ondexxya is under review for the reversal of the
anticoagulant effects of the Factor Xa inhibitors apixaban and
rivaroxaban in patients experiencing uncontrolled or
life-threatening bleeding.
“We will work diligently to address the
Committee’s questions as they review and further consider the data
package supporting the MAA,” said Scott Garland, Portola’s
president and chief executive officer. “We look forward to
continuing the dialogue as we progress toward a formal opinion and
potential European approval early next year.”
Andexanet alfa was approved by the U.S.
Food and Drug Administration 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 and 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 MillerPortola
PharmaceuticalsIR@portola.com
Media Contact:Patrick RyanPure
Communicationspryan@purecommunications.com
Portola Pharmaceuticals (NASDAQ:PTLA)
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