Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the
“Company”) today announced that the Centers for Medicare &
Medicaid Services (“CMS”) has established a unique,
product-specific billing code for Byfavo®1 (remimazolam for
injection), a short-acting sedative for procedures lasting 30
minutes or less. This new Healthcare Common Procedure Coding System
(HCPCS) Level II code (“J-code”) is J2249 “Injection, remimazolam,
1 mg.” The J-code will be effective on July 1, 2023.
J-codes are reimbursement codes used by commercial insurance
plans, Medicare, Medicare Advantage, and other government payers
for physician-administered drugs like Byfavo and are intended to
simplify the claims submission and documentation process,
facilitating access for patients.
“The establishment of a unique J-code for Byfavo is an important
step in facilitating reimbursement and broadening access to this
innovative sedation drug. Byfavo offers a fast onset,
titratability, and rapid recovery for quick discharge, potentially
leading to shorter procedure times. As we expand our acute care
footprint, we believe that the addition of a unique J-code for
Byfavo can add predictability and simplify the reimbursement
process and improve access for patients,” stated Scott Tarriff,
President and Chief Executive Officer of Eagle Pharmaceuticals.
About Eagle Pharmaceuticals, Inc. Eagle is a
fully integrated pharmaceutical company with research and
development, clinical, manufacturing and commercial expertise.
Eagle is committed to developing innovative medicines that result
in meaningful improvements in patients’ lives. Eagle’s
commercialized products include vasopressin, PEMFEXY®, RYANODEX®,
BENDEKA®, BELRAPZO®, TREAKISYM® (Japan), and BYFAVO® and BARHEMSYS®
through its wholly owned subsidiary Acacia Pharma Inc. Eagle’s
oncology and CNS/metabolic critical care pipeline includes product
candidates with the potential to address underserved therapeutic
areas across multiple disease states. Additional information is
available on Eagle’s website at www.eagleus.com.
Forward-Looking Statements This press release
contains “forward-looking statements” within the meaning of the
Private Securities Litigation Reform Act of 1995, as amended, and
other securities law. Forward-looking statements are statements
that are not historical facts. Words and phrases such as
“anticipated,” “forward,” “will,” “would,” “could,” “should,”
“may,” “remain,” “potential,” “prepare,” “expected,” “believe,”
“plan,” “future,” “believe,” “guidance,” “project,” “estimate,”
“intend,” “advance,” “continue” and similar expressions are
intended to identify forward-looking statements. These statements
include, but are not limited to, statements with respect to: the
effectiveness date of the J-code; the anticipated impacts of the
J-code, including its effectiveness in facilitating reimbursement
and broadening access to Byfavo; the Company’s ability to manage
its bendamustine franchise and expand its acute care footprint;
potential benefits of Byfavo; the Company’s ability to obtain and
maintain regulatory approval of its products and product
candidates; the potential market opportunity for the Company’s
products or product candidates, including for Byfavo; and the
ability of the Company to obtain and maintain coverage and adequate
reimbursement for its products. All of such statements are subject
to certain risks and uncertainties, many of which are difficult to
predict and generally beyond the Company’s control, that could
cause actual results to differ materially from those expressed in,
or implied or projected by, the forward-looking information and
statements. Such risks and uncertainties include, but are not
limited to: the risk that the anticipated benefits of the Company’s
acquisition of Acacia are not realized; the ability of Enalare to
achieve milestones and deliverables under the BARDA agreement and
achieve successful results in the development of ENA-001 and the
Company’s ability to exercise its option to acquire the remaining
outstanding share capital of Enalare; the impacts of the COVID-19
pandemic and geopolitical events such as the conflict in Ukraine,
including disruption or impact in the sales of the Company's
marketed products, interruptions or other adverse effects to
clinical trials, delays in regulatory review, manufacturing and
supply chain interruptions, adverse effects on healthcare systems,
disruption in the operations of the Company's third party partners
and disruption of the global economy, and the overall impact of the
COVID-19 pandemic or other events on the Company's business,
financial condition and results of operations; macroeconomic
conditions, including rising inflation and uncertain credit and
financial markets; whether the Company will incur unforeseen
expenses or liabilities or other market factors; whether the
Company will successfully implement its development plan for its
product candidates; delay in or failure to obtain regulatory
approval of the Company's or its partners’ product candidates;
whether the Company can successfully market and commercialize its
product candidates; the success of the Company's relationships with
its partners; the availability and pricing of third party sourced
products and materials; the outcome of litigation involving any of
its products or that may have an impact on any of our products;
successful compliance with the FDA and other governmental
regulations applicable to product approvals, manufacturing
facilities, products and/or businesses; general economic
conditions, including the potential adverse effects of public
health issues, including the COVID-19 pandemic and geopolitical
events, on economic activity and the performance of the financial
markets generally; the strength and enforceability of the Company's
intellectual property rights or the rights of third parties;
competition from other pharmaceutical and biotechnology companies
and the potential for competition from generic entrants into the
market; the risks inherent in the early stages of drug development
and in conducting clinical trials; and any unanticipated factors in
addition to the foregoing that may impact the Company’s financial
and business projections and guidance and may cause the Company’s
actual results and outcomes to materially differ from its
projections and guidance; and those risks and uncertainties
identified in the “Risk Factors” sections of the Company's Annual
Report on Form 10-K for the year ended December 31, 2022, filed
with the Securities and Exchange Commission (the “SEC”) on March
23, 2023, and its other subsequent filings with the SEC. Readers
are cautioned not to place undue reliance on these forward-looking
statements. All forward-looking statements contained in this press
release speak only as of the date on which they were made. Except
to the extent required by law, the Company undertakes no obligation
to update such statements to reflect events that occur or
circumstances that exist after the date on which they were
made.
Investor Relations for Eagle Pharmaceuticals,
Inc.: Lisa M. WilsonIn-Site Communications, Inc. T:
212-452-2793 E: lwilson@insitecony.com
Important Safety Information for
BYFAVO™ (remimazolam) Injection
IndicationsBYFAVO is a benzodiazepine indicated
for the induction and maintenance of procedural sedation in adults
undergoing procedures lasting 30 minutes or less.
Important Safety Information
WARNING: PERSONNEL AND EQUIPMENT FOR MONITORING AND
RESUSCITATION AND RISKS FROM CONCOMITANT USE WITH OPIOID
ANALGESICS
Personnel and Equipment for Monitoring and
Resuscitation
- Only personnel trained in the administration of
procedural sedation, and not involved in the conduct of the
diagnostic or therapeutic procedure, should administer
BYFAVO.
- Administering personnel must be trained in the
detection and management of airway obstruction, hypoventilation,
and apnea, including the maintenance of a patent airway, supportive
ventilation, and cardiovascular resuscitation.
- BYFAVO has been associated with hypoxia, bradycardia,
and hypotension. Continuously monitor vital signs during sedation
and during the recovery period.
- Resuscitative drugs, and age- and size-appropriate
equipment for bag-valve-mask–assisted ventilation must be
immediately available during administration of
BYFAVO.
Risks From Concomitant Use With Opioid Analgesics and
Other Sedative-HypnoticsConcomitant use of
benzodiazepines, including BYFAVO, and opioid analgesics may result
in profound sedation, respiratory depression, coma, and death. The
sedative effect of intravenous BYFAVO can be accentuated by
concomitantly administered CNS depressant medications, including
other benzodiazepines and propofol. Continuously monitor patients
for respiratory depression and depth of sedation.
Contraindication BYFAVO is contraindicated in
patients with a history of severe hypersensitivity reaction to
dextran 40 or products containing dextran 40.
Personnel and Equipment for Monitoring and
ResuscitationClinically notable hypoxia, bradycardia, and
hypotension were observed in Phase 3 studies of BYFAVO.
Continuously monitor vital signs during sedation and through the
recovery period. Only personnel trained in the administration of
procedural sedation, and not involved in the conduct of the
diagnostic or therapeutic procedure, should administer BYFAVO.
Administering personnel must be trained in the detection and
management of airway obstruction, hypoventilation, and apnea,
including the maintenance of a patent airway, supportive
ventilation, and cardiovascular resuscitation. Resuscitative drugs,
and age- and size-appropriate equipment for bag-valve-mask–assisted
ventilation must be immediately available during administration of
BYFAVO. Consider the potential for worsened cardiorespiratory
depression prior to using BYFAVO concomitantly with other drugs
that have the same potential (e.g., opioid analgesics or other
sedative-hypnotics). Administer supplemental oxygen to sedated
patients through the recovery period. A benzodiazepine reversal
agent (flumazenil) should be immediately available during
administration of BYFAVO.
Risks From Concomitant Use With Opioid Analgesics and
Other Sedative-HypnoticsConcomitant use of BYFAVO and
opioid analgesics may result in profound sedation, respiratory
depression, coma, and death. The sedative effect of IV BYFAVO can
be accentuated when administered with other CNS depressant
medications (eg, other benzodiazepines and propofol). Titrate the
dose of BYFAVO when administered with opioid analgesics and
sedative-hypnotics to the desired clinical response. Continuously
monitor sedated patients for hypotension, airway obstruction,
hypoventilation, apnea, and oxygen desaturation. These
cardiorespiratory effects may be more likely to occur in patients
with obstructive sleep apnea, the elderly, and ASA-PS class III or
IV patients.
Hypersensitivity Reactions BYFAVO contains
dextran 40, which can cause hypersensitivity reactions, including
rash, urticaria, pruritus, and anaphylaxis. BYFAVO is
contraindicated in patients with a history of severe
hypersensitivity reaction to dextran 40 or products containing
dextran 40.
Neonatal SedationUse of benzodiazepines during
the later stages of pregnancy can result in sedation (respiratory
depression, lethargy, hypotonia) in the neonate. Observe newborns
for signs of sedation and manage accordingly.
Pediatric NeurotoxicityPublished animal studies
demonstrate that anesthetic and sedation drugs that block NMDA
receptors and/or potentiate GABA activity increase neuronal
apoptosis in the developing brain and result in long-term cognitive
deficits when used for longer than 3 hours. The clinical
significance of this is not clear. However, the window of
vulnerability to these changes is believed to correlate with
exposures in the third trimester of gestation through the first
several months of life but may extend out to approximately 3 years
of age in humans.
Anesthetic and sedation drugs are a necessary part of the care
of children needing surgery, other procedures, or tests that cannot
be delayed, and no specific medications have been shown to be safer
than any other. Decisions regarding the timing of any elective
procedures requiring anesthesia should take into consideration the
benefits of the procedure weighed against the potential risks.
Adverse ReactionsThe most common adverse
reactions reported in >10% of patients (N=630) receiving BYFAVO
5-30 mg (total dose) and undergoing colonoscopy (two studies) or
bronchoscopy (one study) were: hypotension, hypertension, diastolic
hypertension, systolic hypertension, hypoxia, and diastolic
hypotension.
Use in Specific PopulationsPregnancyThere are
no data on the specific effects of BYFAVO on pregnancy.
Benzodiazepines cross the placenta and may produce respiratory
depression and sedation in neonates. Monitor neonates exposed to
benzodiazepines during pregnancy and labor for signs of sedation
and respiratory depression.
LactationMonitor infants exposed to BYFAVO through breast milk
for sedation, respiratory depression, and feeding problems. A
lactating woman may consider interrupting breastfeeding and pumping
and discarding breast milk during treatment and for 5 hours after
BYFAVO administration.
Pediatric UseSafety and effectiveness in pediatric patients have
not been established. BYFAVO should not be used in patients less
than 18 years of age.
Geriatric UseNo overall differences in safety or effectiveness
were observed between these subjects and younger subjects. However,
there is a potential for greater sensitivity (eg, faster onset,
oversedation, confusion) in some older individuals. Administer
supplemental doses of BYFAVO slowly to achieve the level of
sedation required and monitor all patients closely for
cardiorespiratory complications.
Hepatic ImpairmentIn patients with severe hepatic impairment,
the dose of BYFAVO should be carefully titrated to effect.
Depending on the overall status of the patient, lower frequency of
supplemental doses may be needed to achieve the level of sedation
required for the procedure. All patients should be monitored for
sedation-related cardiorespiratory complications.
Abuse and DependenceBYFAVO is a federally
controlled substance (CIV) because it contains remimazolam which
has the potential for abuse and physical dependence.
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