-PDUFA Date of July 23, 2017-
Eagle Pharmaceuticals (Nasdaq:EGRX) (“Eagle” or “the Company”)
announced today that their 505(b)(2) New Drug Application (NDA) for
Ryanodex® (dantrolene sodium) for the treatment of exertional heat
stroke (EHS) has been accepted for filing and granted a priority
review designation by the U.S. Food and Drug Administration (FDA).
The FDA grants priority review to medicines that may offer major
advances in care or provide a treatment option where no adequate
therapy exists. Under the Prescription Drug User Fee Act (PDUFA),
the FDA will aim to complete its review within six months of the
NDA submission; the PDUFA date for the NDA has been set for July
23, 2017.
“There is currently no approved pharmacological treatment for
EHS. If Ryanodex is approved, Eagle will be the first to market
with a potentially transformational therapy. EHS can strike anyone,
but athletes, our military and outdoor workers are especially
vulnerable. We look forward to working with the FDA throughout the
review process and to their expedited decision in July 2017,” said
Scott Tarriff, Chief Executive Officer of Eagle.
“The number of injuries associated with exertional heat illness
in the U.S. increased over 130% between 1997 and 2006. And, we
believe the incidence of EHS is significantly under-reported. There
may be approximately 75,000 cases of EHS annually. Ryanodex will
represent Eagle’s most significant self-launched commercial product
and we are continuing to build our commercial capabilities to serve
the healthcare profession upon approval,” added David Pernock,
President and Chief Commercial Officer of Eagle
Pharmaceuticals.
The NDA is supported by safety and efficacy data from a
controlled clinical trial in EHS patients, and preclinical data
from animal studies conducted under the ‘Animal Rule’ to further
support the efficacy of Ryanodex. The clinical study supported the
known and well-characterized safety profile of Ryanodex and
demonstrated that administration of Ryanodex in addition to body
cooling showed substantial evidence of increased clinically
meaningful effectiveness in treating patients with EHS, compared to
body cooling alone. In addition, animal data provided further
evidence supporting the efficacy of Ryanodex in the treatment of
this rare and life-threatening condition.
“We evaluated Ryanodex in our clinical study conducted in a
real-world acute care setting, and in a well-established animal
model. Clinical data showed that Ryanodex offered a clinically
meaningful benefit to EHS patients when combined with traditional
cooling methods, which is further supported by statistically
significant results from our animal work,” said Adrian Hepner, MD,
PhD, Chief Medical Officer of Eagle Pharmaceuticals.
Information regarding Eagle’s pivotal animal study can be found
in Eagle’s press release dated December 13, 2016. Additional
information regarding Eagle’s clinical study can be found in
Eagle’s press release dated December 17, 2015.
About EHS
EHS is a sudden and unpredictable disorder that constitutes a
medical emergency, which may result in severe multi-organ
dysfunction and death. EHS is more commonly seen in young people
undergoing exertional physical activity in a hot weather
environment, and is one of the leading causes of death in young
athletes and military personnel in non-combat situations. EHS cases
are also observed in outdoor workers, firefighters, and people
randomly performing intense recreational physical activity.
Currently, there is no approved drug product for the treatment
of EHS, one of the most severe forms of heat-related illness,
characterized by core body temperature of 104° F (40° C) or greater
and significant neurological dysfunction. EHS carries high rates of
morbidity and mortality. The central nervous system is particularly
sensitive to hyperthermia, which may lead to severe neurologic
complications and permanent brain damage.
About Ryanodex
RYANODEX® (dantrolene sodium) for injectable suspension is
indicated for the treatment of malignant hyperthermia (“MH”) in
conjunction with appropriate supportive measures, and for the
prevention of malignant hyperthermia in patients at high risk.
In February 2015, RYANODEX® was granted seven years of U.S.
market exclusivity for the treatment of MH by the U.S. Food and
Drug Administration (“FDA”).
Important Safety Information
RYANODEX® is not a substitute for appropriate supportive
measures in the treatment of malignant hyperthermia, including:
Discontinuing triggering anesthetic agents
Increasing oxygen
Managing the metabolic acidosis
Instituting cooling when necessary
Administering diuretics to prevent late kidney injury due to
myoglobinuria (the amount of mannitol in RYANODEX® is insufficient
to maintain diuresis).
Precautions should be taken when administering RYANODEX®
preoperatively for the prevention of malignant hyperthermia,
including monitoring vital signs, avoiding known triggering agents,
and monitoring for early clinical and metabolic signs of malignant
hyperthermia that may indicate additional treatment is needed.
The administration of dantrolene sodium is associated with loss
of grip strength and weakness in the legs, as well as drowsiness,
dizziness, dysphagia, dyspnea, and decreased inspiratory capacity.
Patients should not be permitted to ambulate without assistance
until they have normal strength and balance. Care must be taken to
prevent extravasation of RYANODEX® into the surrounding tissue due
to the high pH of the reconstituted RYANODEX® suspension and
potential for tissue necrosis.
RYANODEX® full Prescribing Information can be found at
www.RYANODEX.com
About Eagle Pharmaceuticals, Inc.
Eagle is a specialty pharmaceutical company focused on
developing and commercializing injectable products that address the
shortcomings, as identified by physicians, pharmacists and other
stakeholders, of existing commercially successful injectable
products. Eagle’s strategy is to utilize the FDA's 505(b)(2)
regulatory pathway. Additional information is available on the
company’s website at www.eagleus.com
Forward-Looking Statements
This press release contains forward-looking information within
the meaning of the Private Securities Litigation Reform Act of
1995, as amended and other securities laws. Forward-looking
statements are statements that are not historical facts. Words such
as “will,” “may,” “believe,” “intends,” “anticipate(s),” “plan,”
“enables,” “potentially,” “entitles,” and similar expressions are
intended to identify forward-looking statements. These statements
include statements regarding future events including, but not
limited to: Eagle’s ability to gain successful FDA approval of
Ryanodex® for Exertional Heat Stroke and the impact, if any of such
approval; the timing and level of success of a future launch of
Ryanodex® for Exertional Heat Stroke; difficulties or delays in
manufacturing; the availability and pricing of third party sourced
products and materials; the strength of the patent portfolio
protecting Ryanodex® and the ability of Eagle to defend against
third party attempts to design around or invalidate those patents;
successful compliance with FDA and other governmental regulations
applicable to manufacturing facilities, products and/or businesses;
the commercial success of Eagle’s commercial portfolio, including
Ryanodex® for Exertional Heat Stroke once launched; the ability of
Eagle to deliver sustained shareholder value over time; and other
factors that are discussed in Eagle’s Annual Report on Form 10-K
for the year ended December 31, 2016, and its other filings with
the U.S. Securities and Exchange Commission. All of such statements
are subject to certain risks and uncertainties, many of which are
difficult to predict and generally beyond Eagle’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 include, but are not limited
to whether Eagle’s management and/or board of directors will be
effective in managing Eagle’s business and future growth, as well
as the other risks described in Eagle’s filings with the U.S.
Securities and Exchange Commission. Readers are cautioned not to
place undue reliance on these forward-looking statements that speak
only as of the date hereof, and we do not undertake any obligation
to revise and disseminate forward-looking statements to reflect
events or circumstances after the date hereof, or to reflect the
occurrence of or non-occurrence of any events.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20170327005232/en/
Investor Relations for Eagle Pharmaceuticals, Inc.:Lisa
M. Wilson, 212-452-2793lwilson@insitecony.comorMediaAleisia
Gibson Wright, 201-423-7760awright@eagleus.com
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