U.S. FDA Assigns PDUFA Date to Portola Pharmaceuticals’ Prior Approval Supplement for the Large-Scale Generation 2 Andexxa ...
12 Septembre 2018 - 12:06AM
Portola Pharmaceuticals, Inc.® (Nasdaq:PTLA) today announced that
the U.S. Food and Drug Administration (FDA) has acknowledged
receipt of the Company’s Prior Approval Supplement (PAS) filing for
the large-scale Generation 2 manufacturing process for
Andexxa® [coagulation factor Xa (recombinant),
inactivated-zhzo]. The PAS has been assigned a Prescription Drug
User Fee Act (PDUFA) date of December 31, 2018. If accepted
and approved, the PAS will allow for the 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.
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
our ability to supply a broad commercial launch of Andexxa in the
United States. Risks that contribute to the uncertain nature of the
forward-looking statements include: 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; 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 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 |
Patrick Ryan |
Portola
Pharmaceuticals |
Pure
Communications |
ir@portola.com |
pryan@purecommunications.com |
Portola Pharmaceuticals (NASDAQ:PTLA)
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