European CHMP Maintains Negative Opinion on Portola Pharmaceuticals’ Betrixaban Following Appeal
27 Juillet 2018 - 2:24PM
Portola Pharmaceuticals, Inc.® (Nasdaq:PTLA) today announced that
the Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA) has issued a final recommendation
on betrixaban for the prevention of venous thromboembolism (VTE) in
adult patients hospitalized for an acute medical illness with risk
factors for VTE, including VTE-related death. The CHMP
maintained its negative opinion following a re-examination
procedure requested by the Company.
The CHMP’s position is that betrixaban addresses an
unmet medical need and showed a clinically relevant rate of
prevention of thrombotic events in patients treated with betrixaban
compared to those treated with enoxaparin. However, the
committee did not consider the overall risk-benefit profile
sufficiently robust when considering non-major bleeding in addition
to major bleeding. Portola will continue working with
regulatory authorities in countries outside the European Union
to potentially bring this important new treatment option to
patients as quickly as possible.
“We are disappointed by the Committee’s
assessment given both the unmet need and the clinically meaningful
outcomes of the APEX trial in reducing VTE and VTE-related deaths
in a vulnerable patient population,” said John T. Curnutte, M.D.,
Ph.D., interim co-president and head of research and development
for Portola. “We remain confident in the potential public health
impact of betrixaban and will maintain focus on the U.S. commercial
launch as we continue to work toward our goal of expanding patient
access to betrixaban around the world.”
The Marketing Authorization Application (MAA)
for betrixaban included data from Portola’s pivotal Phase 3 APEX
Study, which enrolled 7,513 patients at more than 450 clinical
sites worldwide. The APEX study evaluated oral betrixaban from
hospital admission to home (35 to 42 days) compared with injectable
enoxaparin for 6 to 14 days followed by placebo in assessing the
prevention of VTE in high-risk acutely ill medical patients.
Betrixaban was approved by the U.S. Food and
Drug Administration in June 2017 under the trade name Bevyxxa®.
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
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, and
Andexxa® [coagulation factor Xa (recombinant),
inactivated-zhzo], the first and only antidote for the Factor Xa
inhibitors rivaroxaban and apixaban. The company also is advancing
cerdulatinib, a Syk/JAK inhibitor for the treatment of hematologic
cancers.
Forward-Looking StatementsThis
announcement contains forward-looking statements, including
statements relating to Portola Pharmaceuticals' expectations
regarding the regulatory and development status of betrixaban.
These statements are subject to significant risks and
uncertainties, and actual results could differ materially from
those projected. These risks and uncertainties include, without
limitation, risks and uncertainties related to the regulatory and
development process for betrixaban in Europe and other countries,
risks and uncertainties that physicians may not see the benefits of
utilizing betrixaban or Andexxa for the indications which they are
approved; the ability of Portola to continue to manufacture our
products and to expand approved manufacturing facilities; the
possibility of unfavorable results from additional studies of
betrixaban; the risk that the EMA may not approve Andexxa in the
currently anticipated timelines or at all, and that any marketing
approvals may have significant limitations on its use; the risk
that Portola may not obtain additional regulatory approvals
necessary to expand approved indications for Andexxa; and other
general business risks which could have a material adverse impact
on Portola's business, including risks associated with the launch
of Portola's products; regulatory actions or delays or government
regulation generally; Portola's ability to obtain or maintain
proprietary intellectual property protection; the particular
prescribing preferences of physicians and patients; global trends
toward health care cost containment, including government, payor
and general public pricing and reimbursement pressures; general
economic and industry conditions, including the effects of the
persistently weak economic and financial environment in many
countries; safety, quality or manufacturing issues. Risks and
uncertainties relating to Portola Pharmaceuticals and its
business can be found in the “Risk Factors” section of Portola
Pharmaceuticals’ Annual Report on Form 10-K for 2017, which was
filed with the SEC on March 1, 2018, as updated by
subsequent periodic reports filed by Portola with the SEC,
including Quarterly Reports on Form 10-Q and Current Reports on
Form 8-K which are deemed “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.
Investor
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Media
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Cara Miller |
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Patrick Ryan |
Portola
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pryan@purecommunications.com |
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