Merck Receives Positive CHMP Opinion for Investigational Antibiotic ZERBAXA™ (Ceftolozane and Tazobactam)
July 27, 2015 7:30 am ET
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.
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
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.
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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
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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
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and other protections for innovative products; and the exposure to
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The company undertakes no obligation to publicly update any
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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.
Pam Eisele, 267-305-3558
Robert Consalvo, 908-236-1127
Joseph Romanelli, 908-740-1986
Justin Holko, 908-740-1879