Portola Pharmaceuticals Provides Update on Biologics License Application (BLA) for AndexXa® (andexanet alfa)
22 Décembre 2017 - 11:23PM
Portola Pharmaceuticals, Inc.® (Nasdaq:PTLA) today announced that
the U.S. Food and Drug Administration (FDA) will extend its review
of the Biologics License Application (BLA) for AndexXa® (andexanet
alfa) by 90 days. The company recently submitted additional data
requested by the agency for the ongoing ANNEXA-4 study as part of
the continuing review process, which constitutes an amendment to
the submission. Therefore, the agency has instituted an extension
to allow more time for a thorough review of the information
provided and to work with the company on labeling and
post-marketing commitments. In correspondence dated and
issued today, the FDA communicated that the action date will move
from February 3, 2018 to May 4, 2018.
Portola is developing AndexXa as a universal
reversal agent for patients anticoagulated with an oral or
injectable Factor Xa inhibitor who experience a serious
uncontrolled or life-threatening bleeding event or who require
urgent or emergency surgery. The BLA seeks initial approval of
AndexXa for reversal of the anticoagulant effects of apixaban and
rivaroxaban in patients experiencing uncontrolled or
life-threatening bleeding.
Major bleeding (e.g., intracranial hemorrhage,
gastrointestinal bleeding and bleeding into other critical organs)
in patients taking Factor Xa inhibitor anticoagulants has become a
significant cause of hospital admissions, morbidity and patient
mortality. In 2016, approximately 90,000 patients in the U.S.
treated with oral Factor Xa inhibitors were subsequently admitted
to the hospital due to bleeding. Including patients taking the
injectable Factor Xa inhibitor enoxaparin, it is estimated that
more than 150,000 U.S. patients could benefit from an antidote
annually.
Andexanet alfa is also under review by the
European Commission of the European Medicines Agency (EMA). A final
decision by the European Commission on the marketing authorization
application (MAA) for andexanet alfa is anticipated in the first
half of 2018.
About AndexXa
AndexXa is a recombinant protein specifically
designed to bind to Factor Xa inhibitors and rapidly reverse their
anticoagulant effect. AndexXa is a modified form of the human
Factor Xa molecule, an enzyme that helps blood clot. AndexXa works
by acting as a decoy for oral and injectable Factor Xa inhibitors,
which target and bind to Factor Xa, which allows them to exert
their anticoagulant effect. When AndexXa is given to a patient with
Factor Xa inhibitor-related bleeding, it binds to the Factor Xa
inhibitor and prevents it from inhibiting the activity of Factor Xa
and reversing the anticoagulant effects of the inhibitor.
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’s first medicine Bevyxxa®
(betrixaban), an oral, once-daily Factor Xa inhibitor, was approved
by the U.S. Food and Drug Administration in June
2017. The company is also working to advance two clinical programs
for 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 http://www.portola.com and follow the Company on
Twitter @Portola_Pharma.
Investor Contact: Cara
Miller Portola Pharmaceuticals
IR@portola.com
Media Contact:Patrick RyanW2O
Grouppryan@w2ogroup.com
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