Merck (NYSE:MRK), known as MSD outside the United States and
Canada, today announced that the Committee for Medicinal Products
for Human Use (CHMP) of the European Medicines Agency (EMA) has
adopted a positive opinion recommending approval of the
investigational antibiotic ZERBAXA™ (ceftolozane and tazobactam)
for the treatment of the following infections in adults:
complicated intra-abdominal infections, acute pyelonephritis, and
complicated urinary tract infections.
The CHMP positive opinion will be reviewed by the European
Commission. If the European Commission affirms the CHMP opinion, it
will grant a centralized marketing authorization with unified
labeling that is valid in the 28 countries that are members of the
European Union, as well as European Economic Area members, Iceland,
Liechtenstein and Norway.
About ZERBAXA
ZERBAXA (ceftolozane and tazobactam) for injection (1.5 g) is an
antibacterial combination product for intravenous infusion
consisting of the cephalosporin antibacterial drug ceftolozane
sulfate and the beta-lactamase inhibitor tazobactam sodium.
ZERBAXA is approved in the United States and is indicated in
adult patients for the treatment of complicated urinary tract
infections (cUTI), including pyelonephritis, caused by the
following Gram-negative microorganisms: Escherichia coli,
Klebsiella pneumoniae, Proteus mirabilis, and Pseudomonas
aeruginosa. ZERBAXA used in combination with metronidazole is
indicated in adult patients for the treatment of complicated
intra-abdominal infections (cIAI) caused by the following
Gram-negative and Gram-positive microorganisms: Enterobacter
cloacae, Escherichia coli, Klebsiella oxytoca, Klebsiella
pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Bacteroides
fragilis, Streptococcus anginosus, Streptococcus constellatus, and
Streptococcus salivarius.
To reduce the development of drug-resistant bacteria and
maintain the effectiveness of ZERBAXA (ceftolozane and tazobactam)
and other antibacterial drugs, ZERBAXA should be used only to treat
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 Information about ZERBAXA
Patients with renal impairment: Decreased efficacy of
ZERBAXA has been observed in patients with baseline CrCl of 30 to
≤50 mL/min. In a clinical trial, patients with cIAIs with CrCl ≥50
mL/min had a clinical cure rate of 85.2% when treated with ZERBAXA
plus metronidazole vs 87.9% when treated with meropenem. In the
same trial, patients with CrCl 30 to ≤50 mL/min had a clinical cure
rate of 47.8% when treated with ZERBAXA plus metronidazole vs 69.2%
when treated with meropenem. A similar trend was also seen in the
cUTI trial. Monitor CrCl at least daily in patients with changing
renal function and adjust the dose of ZERBAXA accordingly.
Hypersensitivity: ZERBAXA is contraindicated in patients
with known serious hypersensitivity to ceftolozane/tazobactam,
piperacillin/tazobactam, or other members of the beta-lactam class.
Serious and occasionally fatal hypersensitivity (anaphylactic)
reactions have been reported in patients receiving beta-lactam
antibacterials. Before initiating therapy with ZERBAXA, make
careful inquiry about previous hypersensitivity reactions to
cephalosporins, penicillins, or other beta-lactams. If an
anaphylactic reaction to ZERBAXA occurs, discontinue use and
institute appropriate therapy.
Clostridium difficile–associated diarrhea (CDAD),
ranging from mild diarrhea to fatal colitis, has been reported with
nearly all systemic antibacterial agents, including ZERBAXA.
Careful medical history is necessary because CDAD has been reported
to occur more than two months after the administration of
antibacterial agents. If CDAD is confirmed, antibacterial use not
directed against C. difficile should be discontinued, if
possible.
Development of drug-resistant bacteria: Prescribing
ZERBAXA in the absence of a proven or strongly suspected bacterial
infection is unlikely to provide benefit to the patient and
increases the risk of the development of drug-resistant
bacteria.
Adverse reactions: The most common adverse reactions
occurring in ≥5% of patients were headache (5.8%) in the cUTI
trial, and nausea (7.9%), diarrhea (6.2%) and pyrexia (5.6%) in the
cIAI trial.
About Merck
Today's Merck is a global healthcare leader working to help the
world be well. Merck is known as MSD outside of the United States
and Canada. Through our prescription medicines, vaccines, biologic
therapies and animal health products, we work with customers and
operate in more than 140 countries to deliver innovative health
solutions. We also demonstrate our commitment to increasing access
to healthcare through far-reaching policies, programs and
partnerships. For more information, visit www.merck.com and connect
with us on Twitter, Facebook and YouTube.
Forward-Looking Statement of Merck & Co., Inc.,
Kenilworth, N.J., USA
This news release of Merck & Co., Inc., Kenilworth, N.J.,
USA (the “company”) includes “forward-looking statements” within
the meaning of the safe harbor provisions of the U.S. Private
Securities Litigation Reform Act of 1995. These statements are
based upon the current beliefs and expectations of the company’s
management and are subject to significant risks and uncertainties.
There can be no guarantees with respect to pipeline products that
the products will receive the necessary regulatory approvals or
that they will prove to be commercially successful. If underlying
assumptions prove inaccurate or risks or uncertainties materialize,
actual results may differ materially from those set forth in the
forward-looking statements.
Risks and uncertainties include but are not limited to, general
industry conditions and competition; general economic factors,
including interest rate and currency exchange rate fluctuations;
the impact of pharmaceutical industry regulation and health care
legislation in the United States and internationally; global trends
toward health care cost containment; technological advances, new
products and patents attained by competitors; challenges inherent
in new product development, including obtaining regulatory
approval; the company’s ability to accurately predict future market
conditions; manufacturing difficulties or delays; financial
instability of international economies and sovereign risk;
dependence on the effectiveness of the company’s patents and other
protections for innovative products; and the exposure to
litigation, including patent litigation, and/or regulatory
actions.
The company undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new information,
future events or otherwise. Additional factors that could cause
results to differ materially from those described in the
forward-looking statements can be found in the company’s 2014
Annual Report on Form 10-K and the company’s other filings with the
Securities and Exchange Commission (SEC) available at the SEC’s
Internet site (www.sec.gov).
Please see Prescribing Information for ZERBAXA (ceftolozane
and tazobactam) at
http://zerbaxa.com/pdf/PrescribingInformation.pdf.
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MerckMedia:Pam Eisele, 267-305-3558orRobert Consalvo,
908-236-1127orInvestors:Joseph Romanelli, 908-740-1986orJustin
Holko, 908-740-1879
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