Portola Pharmaceuticals Provides Update on European Marketing Authorization Application for Betrixaban
12 Décembre 2017 - 2:30PM
Portola Pharmaceuticals, Inc.® (Nasdaq:PTLA) today announced that
the Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA) has requested additional
information related to the Marketing Authorization Application
(MAA) for betrixaban.
The CHMP has provided the Day 195 List of
Outstanding Issues (LoOI) to the company with a request for
responses during the next available submission window of January
23, 2018. Based on this new timeline, the Company expects the
CHMP to issue an opinion later in the first quarter of 2018.
“We have had a productive ongoing dialogue with
the CHMP throughout the MAA process and believe the CHMP questions
can be addressed with existing clinical data,” said John T.
Curnutte, M.D., Ph.D., executive vice president, research and
development. “We look forward to continuing to work with the EMA to
address the unmet need in Europe for extended duration prophylaxis
of venous thromboembolism in acute medically ill patients.”
The MAA for betrixaban includes 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 for 35 to 42 days compared with injectable
enoxaparin for 6 to 14 days followed by placebo in assessing the
prevention of venous thromboembolism (VTE) in high-risk acutely ill
medical patients.
Results from the APEX Study have been peer-reviewed and
published in The New England Journal of
Medicine1, Circulation2 and the American Heart
Journal.3
Betrixaban was approved by the U.S. Food and Drug Administration
in June 2017 under the trade name Bevyxxa®.
Important U.S. Safety Information for Bevyxxa
(betrixaban) capsules
INDICATION Bevyxxa is indicated for the
prophylaxis of venous thromboembolism (VTE) in adult patients
hospitalized for an acute medical illness who are at risk for
thromboembolic complications due to moderate or severe restricted
mobility and other risk factors for
VTE.
LIMITATIONS OF USE The safety and
effectiveness of Bevyxxa have not been established in patients with
prosthetic heart valves because this population has not been
studied. SELECT IMPORTANT
SAFETY INFORMATION
WARNING: SPINAL/EPIDURAL
HEMATOMA EPIDURAL OR
SPINAL HEMATOMAS MAY OCCUR IN PATIENTS TREATED WITH BEVYXXA WHO ARE
RECEIVING NEURAXIAL ANESTHESIA OR UNDERGOING SPINAL PUNCTURE. THE
RISK OF THESE EVENTS MAY BE INCREASED BY THE USE OF IN‑DWELLING
EPIDURAL CATHETERS OR THE CONCOMITANT USE OF MEDICAL PRODUCTS
AFFECTING HEMOSTASIS. THESE HEMATOMAS MAY RESULT IN LONG-TERM OR
PERMANENT PARALYSIS. CONSIDER THESE RISKS WHEN SCHEDULING PATIENTS
FOR SPINAL PROCEDURES. |
CONTRAINDICATIONS
- Active pathological bleeding
- Severe hypersensitivity reaction to Bevyxxa
WARNINGS AND PRECAUTIONS Risk of
Bleeding
- Bevyxxa increases the risk of bleeding and can cause serious
and potentially fatal bleeding
- Concomitant use of drugs affecting hemostasis increases the
risk of bleeding. These include aspirin and other antiplatelet
agents, other anticoagulants, heparin, thrombolytic agents,
selective serotonin reuptake inhibitors, serotonin norepinephrine
reuptake inhibitors, and nonsteroidal anti-inflammatory drugs
(NSAIDs)
- Advise patients of signs and symptoms of blood loss and to
report them immediately or go to an emergency room
- Promptly evaluate any signs or symptoms of blood loss and
consider the need for blood replacement
- Discontinue Bevyxxa in patients with active pathological
bleeding
- There is no established way to reverse the anticoagulant effect
of Bevyxxa, which can be expected to persist for at least 72 hours
after the last dose
- It is unknown whether hemodialysis removes Bevyxxa
- Protamine sulfate, vitamin K, and tranexamic acid are not
expected to reverse the anticoagulant activity of
Bevyxxa
Spinal/Epidural Anesthesia or
Puncture
- When neuraxial anesthesia (spinal/epidural anesthesia) or
spinal/epidural puncture is employed, patients treated with
antithrombotic agents for prevention of thromboembolic
complications are at risk of developing an epidural or spinal
hematoma which can result in long-term or permanent
paralysis
- Do not remove an epidural catheter earlier than 72 hours after
the last administration of Bevyxxa. The next Bevyxxa dose is not to
be administered earlier than 5 hours after the removal of the
catheter. If traumatic puncture occurs, delay the administration of
Bevyxxa for 72 hours
- Monitor patients frequently for signs and symptoms of
neurological impairment (e.g., numbness or weakness of the legs,
bowel or bladder dysfunction). If neurological compromise is noted,
urgent diagnosis and treatment is necessary
- Prior to neuraxial intervention, consider the potential benefit
versus the risk in anticoagulated patients or in patients to be
anticoagulated for thromboprophylaxis
Use in Patients with Severe Renal
Impairment
- Patients with severe renal impairment (CrCl ≥ 15 to
< 30 mL/min computed by Cockcroft-Gault) taking Bevyxxa may have
an increased risk of bleeding events
- Reduce dose of Bevyxxa, monitor patients closely, and promptly
evaluate any signs or symptoms of blood loss in these
patients
Use in Patients on Concomitant P-glycoprotein (P-gp)
Inhibitors
- Patients on concomitant P-gp inhibitors with Bevyxxa may have
an increased risk of bleeding
- Reduce dose of Bevyxxa in patients receiving or starting
concomitant P-gp inhibitors, monitor patients closely, and promptly
evaluate any signs or symptoms of blood loss in these
patients
- Avoid use of Bevyxxa in patients with severe renal impairment
receiving concomitant P‑gp inhibitors
ADVERSE REACTIONS
- The most common adverse reactions with Bevyxxa were related to
bleeding (> 5%)
USE IN SPECIFIC
POPULATIONS Hepatic
Impairment
- Bevyxxa has not been evaluated in patients with hepatic
impairment, because these patients may have intrinsic coagulation
abnormalities
- Bevyxxa is not recommended in patients with hepatic
impairment
Please see additional Important Safety Information and
full Prescribing Information, including the Boxed Warning at
Bevyxxa.com
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.
Forward-looking Statements
This announcement contains forward-looking
statements, including statements relating to Portola
Pharmaceuticals’ expectations regarding the anticipated product
availability of Bevyxxa. These statements are subject to
significant risks and uncertainties and actual results could differ
materially from those projected. Portola
Pharmaceuticals cautions investors not to place undue reliance
on the forward-looking statements contained in this release. These
risks and uncertainties include, without limitation, regulatory
timing projections and other risks and uncertainties related to
regulatory approval for betrixaban in the European Union. Risks and
uncertainties relating to Portola Pharmaceuticals and its
business can be found in the “Risk Factors” section of Portola
Pharmaceuticals’ Quarterly Report on Form 10-Q for the third
quarter of 2017, which was filed with
the SEC on November 9, 2017. 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
Contact: |
|
Media
Contact: |
Michele
Mantynen |
|
Patrick
Ryan |
Portola
Pharmaceuticals |
|
W2O
Group |
IR@portola.com |
|
pryan@w2ogroup.com |
1 Cohen et al. Extended Thromboprophylaxis with Betrixaban in
Acutely Ill Medical Patients. New England Journal of Medicine,
1026; 375.6.
2 Gibson et al. Extended-Duration Betrixaban Reduces the Risk of
Stroke Versus Standard-Dose Enoxaparin Among Hospitalized Medically
Ill Patients. Circulation. 2017; 135(7):648-655.
3 Gibson et al. The safety and efficacy of full versus
reduced-dose betrixaban in the Acute Medically Ill VTE Prevention
With Extended-Duration Betrixaban (APEX) trial. Am Heart J. 2017;
185:93-100.
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