FDA Informs Portola Pharmaceuticals at Mid-Cycle Review for Betrixaban That It Has Not Identified Issues that Require an Advi...
08 Février 2017 - 2:00PM
Portola Pharmaceuticals, Inc.® (Nasdaq:PTLA) today announced that
the U.S. Food and Drug Administration (FDA)’s Center for Drug
Evaluation and Research (CDER) has informed the Company, as part of
its mid-cycle review, that it does not plan to hold an Advisory
Committee meeting for Portola’s New Drug Application (NDA) for
betrixaban. Betrixaban is an oral, once-daily Factor Xa inhibitor
anticoagulant. The NDA for betrixaban, an FDA Fast Track-designated
therapy, is under priority review by the FDA for extended-duration
prophylaxis of venous thromboembolism (VTE) in acute medically ill
patients with risk factors for VTE.
“Based on the APEX data, we remain confident in the potential
for betrixaban to be approved as the first anticoagulant for
extended-duration VTE prophylaxis in high-risk acute medically ill
patients,” said John T. Curnutte, M.D., Ph.D., executive vice
president, research and development, at Portola. “We look forward
to continuing our ongoing discussions with the FDA as part of the
priority review process.”
About VTE in Acute Medically Ill
Patients Acute medically ill patients are those
hospitalized for serious, common medical conditions, including
heart failure, stroke, infection and pulmonary disease. Because of
their underlying disorder or immobilization during hospitalization,
they are at increased risk of VTE, a serious and potentially
life-threatening blood clot (thrombus). VTE, which includes both
deep vein thrombosis (DVT) and pulmonary embolism (PE), is a major
cause of preventable morbidity and mortality and re-hospitalization
in the acute medically ill patient population.
In the G7 countries, an estimated 24 million acute medically ill
patients are hospitalized each year and are at risk of VTE, either
while in the hospital or following discharge. More than 1 million
VTE events and 150,000 VTE-related deaths occur annually in acute
medically ill patients in the G7 countries, despite the standard
use of injectable enoxaparin and other heparins in the hospital.
More than half of VTE events occur after the patient is discharged.
However, no anticoagulant, including enoxaparin or any of the
marketed oral Factor Xa inhibitors, is approved for in-hospital and
extended-duration VTE prophylaxis in acute medically ill patients
who are hospitalized.
About Betrixaban Betrixaban, an
investigational drug, directly inhibits the activity of Factor Xa,
an important validated target in the blood coagulation pathway, to
prevent life-threatening thrombosis. Betrixaban has distinct
properties that may allow it to demonstrate clinical benefit
without the significant imbalance in the risk of major bleeding
seen with other agents in the class. These include a 19-25-hour
half-life for once-daily dosing; a low peak-to-trough drug
concentration ratio that reduces anticoagulant variability; low
renal clearance; and no significant CYP3A4 metabolism, which may
reduce the risk of drug-drug interactions.
In the EU, the European Medicines Agency’s Committee for
Medicinal Products for Human Use (CHMP) is reviewing the Marketing
Authorization Application for betrixaban under a standard 210-day
review period.
About Portola Pharmaceuticals, Inc.
Portola Pharmaceuticals is a biopharmaceutical company developing
product candidates that could significantly advance the fields of
thrombosis and other hematologic diseases. The Company is advancing
three programs, including betrixaban, an oral, once-daily Factor Xa
inhibitor; AndexXa™ (andexanet alfa), a recombinant protein
designed to reverse the anticoagulant effect in patients treated
with an oral or injectable Factor Xa inhibitor; and cerdulatinib, a
Syk/JAK inhibitor in development to treat hematologic cancers.
Portola's partnered program is focused on developing selective Syk
inhibitors for inflammatory conditions. For more information, visit
www.portola.com and follow the Company on Twitter
@Portola_Pharma.
Forward-looking Statements Statements
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 development
of our product candidates, our regulatory applications and
estimated timelines associated therewith, including our expression
of confidence in the potential for betrixaban to be approved as the
first anticoagulant for extended-duration VTE prophylaxis in
high-risk acute medically ill patients. Risks that contribute to
the uncertain nature of the forward-looking statements include: our
potential failure to obtain regulatory approval for one or more of
our product candidates, our expectation that we will incur losses
for the foreseeable future and will need additional funds to
finance our operations; the results of our clinical trials related
to the efficacy and safety of our product candidates; our potential
inability to manufacture our product candidates on a commercial
scale in a timely or cost-efficient manner; the accuracy of our
estimates regarding expenses and capital requirements; regulatory
developments in the United States and foreign countries; 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, which was filed on November 7, 2016. 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:
Ana Kapor
Portola Pharmaceuticals
ir@portola.com
Media Contact:
Julie Normart
Pure Communications
jnormart@purecommunications.com
415.946.1087
Portola Pharmaceuticals (NASDAQ:PTLA)
Graphique Historique de l'Action
De Juin 2024 à Juil 2024
Portola Pharmaceuticals (NASDAQ:PTLA)
Graphique Historique de l'Action
De Juil 2023 à Juil 2024