Tetraphase Pharmaceuticals Announces Adoption of Commission
Decision Granting Marketing Authorisation Approval in the European
Union for XERAVA™ (eravacycline) for the Treatment of Complicated
Intra-Abdominal Infections
Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH), a biopharmaceutical
company focused on developing and commercializing novel antibiotics
to treat life-threatening multidrug-resistant (MDR) infections,
today announced that the European Commission (EC) has adopted the
Decision granting marketing authorisation for XERAVA (eravacycline)
for injection for the treatment of complicated intra-abdominal
infections (cIAI) in adults in the European Union. In clinical
trials, XERAVA was well-tolerated and achieved high clinical cure
rates in patients with cIAI, demonstrating statistical
non-inferiority to two widely used comparators – ertapenem and
meropenem.
“The European approval of XERAVA, right after our recently
announced FDA approval, marks our second significant regulatory
approval within one month and reflects our commitment to bringing
this novel antibiotic to patients on a global level,” said Guy
Macdonald, President and Chief Executive Officer of Tetraphase. “We
are excited about the approval of XERAVA in Europe, and we remain
on track to launch in Europe via a phased introduction, beginning
with Germany and the UK, in early 2019.”
Mr. Macdonald added, “Once again, we are grateful to the
patients who have participated in our clinical studies, study
investigators, physicians and our dedicated employees for bringing
us to this important milestone for the Company. With the growing
crisis of antibiotic resistance and the limitations of current
empiric treatments for cIAI, the medical community is desperately
in need of new antibiotics. Given its broad spectrum of
antibacterial activity and clinical and safety profile, we believe
XERAVA has the potential to address this need, and we look forward
to a successful launch.”
The European Commission approval follows the positive opinion
issued by the Committee for Medicinal Products for Human Use (CHMP)
and allows Tetraphase to market XERAVA in all countries in the
European Union as well as Iceland, Liechtenstein and Norway. The
decision was based on a comprehensive data package which included
data from the Company’s phase 3 clinical trials investigating
XERAVA in patients with cIAI compared to ertapenem and meropenem.
In the first trial, twice-daily intravenous (IV) XERAVA met the
primary endpoint, demonstrating non-inferiority in clinical cure
versus IV ertapenem. In the second trial, twice-daily IV XERAVA met
the primary endpoint, demonstrating non-inferiority in clinical
cure versus IV meropenem. In both trials, XERAVA was well-tolerated
and achieved high cure rates in patients with Gram-negative
pathogens, including resistant isolates.
“The approval of XERAVA in Europe represents a significant
advancement for patients impacted by serious and life-threatening
infections caused by multidrug-resistant pathogens,” said Matteo
Bassetti, M.D., Ph.D., Head of the Infectious Diseases Division of
the Santa Maria Misericordia University Hospital, Udine, Italy and
Associate Professor of Infectious Diseases of the University of
Udine. “XERAVA’s broad spectrum of coverage against Gram-negative,
Gram-positive and anaerobic bacteria allow it to fill an unmet need
for patients with complicated intra-abdominal infections, and it is
also well-suited as a first-line empiric treatment for appropriate
patients. XERAVA offers an alternative to beta-lactams, including
carbapenems which are experiencing more resistance, making this
important new antibiotic a welcome option for physicians.”
About Complicated Intra-Abdominal
InfectionsIntra-abdominal infection (IAI) is a common
problem in clinical practice and comprises a wide variety of
disease processes. IAI is classified as uncomplicated or
complicated based on the extent of the infection. Complicated
intra-abdominal infections (cIAI) extend beyond the source organ
into the peritoneal space (the space between the two membranes that
separate the organs in the abdominal cavity from the abdominal
wall) as a result of perforation or other damage to the
gastrointestinal tract. cIAI diagnoses include intra-abdominal
abscess, stomach or intestinal perforation, peritonitis,
appendicitis, cholecystitis or diverticulitis. Different bacterial
pathogens are responsible for cIAI, including Gram-negative aerobic
bacteria, Gram-positive bacteria and anaerobic bacteria. Early
detection, containment and appropriate antimicrobial treatment are
essential for the successful treatment of IAI. This is even more
critical with increasing rates of infections caused by
drug-resistant bacteria, which limit the effectiveness of currently
available antibiotics.
Indications and UsageXERAVA is indicated for
the treatment of complicated intra-abdominal infections (cIAI)
caused by susceptible microorganisms: Escherichia coli,
Klebsiella pneumoniae, Citrobacter freundii, Enterobacter cloacae,
Klebsiella oxytoca, Enterococcus faecalis, Enterococcus faecium,
Staphylococcus aureus, Streptococcus anginosus group, Clostridium
perfringens, Bacteroides species, and Parabacteroides distasonis in
patients 18 years or older.
Limitations of UseXERAVA is not indicated for the treatment of
complicated urinary tract infections (cUTI).
UsageTo reduce the development of
drug-resistant bacteria and maintain the effectiveness of XERAVA
and other antibacterial drugs, XERAVA should be used only to treat
or prevent infections that are proven or strongly suspected to be
caused by susceptible bacteria. When culture and
susceptibility information are available, they should be considered
in selecting or modifying antibacterial therapy. In the
absence of such data, local epidemiology and susceptibility
patterns may contribute to the empiric selection of therapy.
Important Safety InformationXERAVA is
contraindicated for use in patients with known hypersensitivity to
eravacycline or to tetracycline-class antibacterial drugs.
Life-threatening hypersensitivity (anaphylactic) reactions have
been reported with XERAVA.
The use of XERAVA during tooth development (last half of
pregnancy, infancy and childhood to the age of 8 years) may cause
permanent discoloration of the teeth (yellow-gray-brown) and enamel
hypoplasia.The use of XERAVA during the second and third trimester
of pregnancy, infancy and childhood up to the age of 8 years may
cause reversible inhibition of bone growth.
Clostridium difficile associated diarrhea (CDAD) has been
reported with use of nearly all antibacterial agents and may range
in severity from mild diarrhea to fatal colitis.
The most common adverse reactions observed in clinical trials
(incidence ≥ 3%) were infusion site reactions (7.7%), nausea
(6.5%), and vomiting (3.7%).
XERAVA is structurally similar to tetracycline-class
antibacterial drugs and may have similar adverse reactions. Adverse
reactions including photosensitivity, pseudotumor cerebri, and
anti-anabolic action which has led to increased BUN, azotemia,
acidosis, hyperphosphatemia, pancreatitis, and abnormal liver
function tests, have been reported for other tetracycline-class
antibacterial drugs, and may occur with XERAVA. Discontinue XERAVA
if any of these adverse reactions are suspected.
To report SUSPECTED ADVERSE REACTIONS, contact
Tetraphase Pharmaceuticals Inc., at 1-833- 7-XERAVA
(1-833-793-7282) or FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch.
About XERAVAXERAVA (eravacycline) for injection
is a tetracycline class antibacterial indicated for the treatment
of complicated intra-abdominal infections (cIAI) in patients 18
years of age and older. It is approved for use in the U.S. and
Europe. XERAVA was investigated for the treatment of cIAI as part
of the Company's IGNITE (Investigating
Gram-Negative
Infections Treated with
Eravacycline) phase 3 programs. In the first
pivotal phase 3 trial in patients with cIAI, twice-daily
intravenous (IV) eravacycline met the primary endpoint by
demonstrating statistical non-inferiority of clinical response
compared to ertapenem and was well-tolerated. In the second phase 3
clinical trial in patients with cIAI, twice-daily IV eravacycline
met the primary endpoint by demonstrating statistical
non-inferiority of clinical response compared to meropenem and was
well-tolerated. In both trials, XERAVA achieved high cure rates in
patients with Gram-negative pathogens, including resistant
isolates.
About Tetraphase Pharmaceuticals,
Inc.Tetraphase is a biopharmaceutical company using its
proprietary chemistry technology to create novel antibiotics for
serious and life-threatening bacterial infections, including those
caused by many of the multidrug-resistant bacteria highlighted as
urgent public health threats by the World Health Organization and
the Centers for Disease Control and Prevention. The Company has
created more than 3,000 novel tetracycline compounds using its
proprietary technology platform. Tetraphase's lead product XERAVA
is approved for the treatment of complicated intra-abdominal
infections (cIAI) by the U.S. Food and Drug Administration and the
European Commission. The Company’s pipeline also includes TP-271
and TP-6076, which are in phase 1 clinical trials. Please visit
www.tphase.com for more company information.
Forward-Looking StatementsAny statements in
this press release about our future expectations, plans and
prospects, including statements regarding our strategy, future
operations, prospects, plans and objectives, and other statements
containing the words "anticipates," "believes," "expects," "plans,"
"will" and similar expressions, constitute forward-looking
statements within the meaning of The Private Securities Litigation
Reform Act of 1995. Actual results may differ materially from those
indicated by such forward-looking statements as a result of various
important factors, including whether eravacycline will be
successfully distributed and marketed and other regulatory and
commercial risk factors discussed in the "Risk Factors" section of
our quarterly report on Form 10-Q for the period ended June 30,
2018, filed with the Securities and Exchange Commission on August
2, 2018. In addition, the forward-looking statements included in
this press release represent our views as of September 20 2018. We
anticipate that subsequent events and developments will cause our
views to change. However, while we may elect to update these
forward-looking statements at some point in the future, we
specifically disclaim any obligation to do so.
Media and Investor Contact:Tetraphase
PharmaceuticalsJennifer Viera617-600-7040jviera@tphase.com
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