Portola Pharmaceuticals Submits Prior Approval Supplement to U.S. FDA for Large-Scale Generation 2 Andexxa Process
31 Août 2018 - 2:30PM
Portola Pharmaceuticals, Inc.® (Nasdaq:PTLA) today announced the
submission of a prior approval supplement (PAS) to the U.S. Food
and Drug Administration (FDA) for the large-scale Generation 2
manufacturing process for Andexxa® [coagulation factor Xa
(recombinant), inactivated-zhzo]. If approved, the PAS will allow
for broad commercial launch of Andexxa in the United States.
Andexxa received both U.S. Orphan Drug and FDA
Breakthrough Therapy designations, and was approved on May 3, 2018
under the FDA's Accelerated Approval pathway. It is the first
and only antidote indicated for patients treated with rivaroxaban
and apixaban, when reversal of anticoagulation is needed due to
life-threatening or uncontrolled bleeding.
“We are pleased that patients are already
benefitting from access to our limited supply Generation 1 product
via an Early Supply Program,” said John Curnutte, M.D., Ph.D.,
interim co-president of Portola and head of research and
development. “With the recent completion of three successful
Generation 2 manufacturing campaigns, we have enough supply to
stock more than 1,000 hospitals, and we look forward to working
with regulatory authorities to achieve our goal of expanding
patient access to this potentially life-saving medicine.”
Based on FDA timelines, the Company expects a
final decision on the PAS in Q1 2019. In Europe, andexanet alfa
received a positive trend vote from the Committee for Medicinal
Products for Human Use (CHMP) of the European Medicines Agency in
February 2018. Pending the submission of additional data requested
by the CHMP, a final CHMP opinion is expected in Q4 2018 with the
potential for approval in Q1 2019.
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 timelines for regulatory review of our PAS and
CHMP opinion in Europe and our ability to supply more than 1,000
hospitals with Generation 2 product, as well as expanding patient
access and the medical and commercial potential 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 or Bevyxxa for the
indications which they are approved; the risk that the FDA may not
accept our PAS for review, may not approve our PAS on anticipated
timelines, or at all and the risk that the FDA may require
additional data before approving our Generation 2 manufacturing
process; 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 the EMA may not approve Andexxa 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 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; 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: |
Media Contact: |
Cara
Miller |
Laurie Masonson |
Portola Pharmaceuticals |
Pure
Communications |
ir@portola.com |
lmasonson@purecommunications.com |
Portola Pharmaceuticals (NASDAQ:PTLA)
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