Portola Pharmaceuticals Provides Update on Bevyxxa® (betrixaban) Commercial Launch
November 21 2017 - 6:22PM
Portola Pharmaceuticals, Inc.® (NASDAQ:PTLA) today announced
that the U.S. Food and Drug Administration (FDA) has extended the
review period for the Company’s Prior Approval Supplement (PAS) for
Bevyxxa® (betrixaban) to allow the agency time to review the entire
submission. The FDA informed the Company today that it will respond
to the PAS request to change the current manufacturing release
specification within the standard 60-day extension period. No
additional information was requested at this time. The new action
date is January 30, 2018.
“As we communicated earlier this month, we’ve
made good progress with the FDA and have established an
agreement in principle on the change to our product release
specification that would allow for the release and distribution of
current product inventory. We also noted that the agency might need
additional time to review our submission,” said Bill Lis, chief
executive officer of Portola. “While the FDA completes its review,
the momentum within the medical community is building. We continue
our commercial and medical education activities in anticipation of
a potential launch by February 2018, and remain committed to
getting Bevyxxa to patients who may benefit from this important and
potentially life-saving new therapy.”
Approved by the FDA on June 23, 2017, Bevyxxa is
the first and only anticoagulant for hospital and extended duration
prophylaxis (35 to 42 days) of 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.
Important U.S. Safety
Information for Bevyxxa (betrixaban) capsules
INDICATIONBevyxxa 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
USEThe 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
HEMATOMAEPIDURAL 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 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
StatementsThis 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, risks and uncertainties related to
regulatory review and our manufacturing and distribution strategy.
There can be no assurance that Portola Pharmaceuticals will be able
to make Bevyxxa commercially available on our anticipated timeline.
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.
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Investor
Contact: |
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Media
Contact: |
Michele Mantynen |
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Patrick Ryan |
Portola
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pryan@w2ogroup.com |
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