U.S. Food and Drug Administration Approves Prior Approval Supplement for Commercial Launch of Portola Pharmaceuticals’ Nove...
December 19 2017 - 10:35AM
Portola Pharmaceuticals, Inc.® (NASDAQ:PTLA) today announced
that the U.S. Food and Drug Administration (FDA) has approved the
Company’s Prior Approval Supplement (PAS) for Bevyxxa® (betrixaban)
ahead of its scheduled January 30th action date, allowing for the
release and distribution of its current product inventory.
The Company plans to initiate commercial launch in early
January 2018 and will provide an update during the next investor
presentation and webcast, scheduled for Tuesday, January 9 (7:00 am
PT/10:00 am ET).
“We are pleased to be able to make Bevyxxa
available to acute medically ill patients at high risk of venous
thromboembolism beginning in January 2018,” said Bill Lis, chief
executive officer of Portola. “VTEs result in
approximately 100,000 deaths annually in the U.S. in acute
medically ill patients – and they are preventable. As
the first and only anticoagulant approved as a single-drug regimen
administered in the hospital and following discharge for a
treatment duration of 35-42 days, Bevyxxa has the potential to
impact public health in the U.S. and beyond, if approved in other
countries. We thank the FDA for its guidance throughout the review
process and look forward to continuing our collaborative efforts
with the agency for the benefit of patients.”
Bevyxxa was approved by the FDA on June 23, 2017
as a single-drug regimen in the hospital and following discharge
for a treatment duration of 35-42 days for the prevention 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
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 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 the
timing of product availability for Bevyxxa. 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:
Michele
Mantynen
Portola Pharmaceuticals
ir@portola.com
Media Contact:Patrick RyanW2O
Grouppryan@w2ogroup.com
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