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 ZERBAXA® 3g dose
(ceftolozane and tazobactam) for an additional indication for the
treatment of hospital-acquired pneumonia (HAP), including
ventilator-associated pneumonia (VAP), in adults. Consideration
should be given to official guidance on the appropriate use of
antibacterial agents.
The CHMP positive opinion will now be considered by the European
Commission. If the European Commission affirms the CHMP opinion, it
will grant an update to the 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. Supplemental marketing
authorization applications for ZERBAXA for the treatment of
nosocomial pneumonia, including VAP, are also under regulatory
review in other countries, including Canada and Japan.
ZERBAXA is an antibacterial combination product for intravenous
infusion consisting of the cephalosporin antibacterial drug
ceftolozane sulfate and the beta-lactamase inhibitor tazobactam
sodium.
“We are pleased with the CHMP’s positive opinion recommending
approval of ZERBAXA for the treatment of HAP, including VAP, which
marks an important step towards providing a new option for medical
professionals treating critically ill patients in the hospital
setting,” said Dr. Nicholas Kartsonis, senior vice president,
infectious diseases and vaccines, global clinical development,
Merck Research Laboratories. “This milestone reflects the valued
contributions of all the health care professionals and patients
involved in the pivotal ASPECT-NP trial.”
According to a recent publication, ventilated patients with
hospital-acquired bacterial pneumonia (HABP) have a higher rate of
mortality (39%) than those with ventilator-associated bacterial
pneumonia (VABP) (27%). In addition, Pseudomonas aeruginosa is the
most common Gram-negative pathogen in HABP/VABP and is becoming
increasingly difficult to treat.
The proposed additional indication for ZERBAXA is based on
results of the pivotal Phase 3 ASPECT-NP trial that evaluated the
efficacy and safety of ZERBAXA at a 3g dose for the treatment of
adult patients with HAP, including VAP. The results of the
ASPECT-NP trial were presented at the 29th European Congress of
Clinical Microbiology & Infectious Diseases, in Amsterdam,
Netherlands, in April 2019.
ZERBAXA 1.5g (ceftolozane 1g and tazobactam 0.5g) was approved
by the European Commission in 2015 for use as indicated in adult
patients with complicated urinary tract infections (cUTI), acute
pyelonephritis, and complicated intra-abdominal infections
(cIAI).
Additional Important Safety Information about ZERBAXA
(ceftolozane and tazobactam)
Patients with changing renal function: Dose adjustment is
required for patients with creatinine clearance (CrCl) 50 mL/min or
less. All doses of ZERBAXA are administered over 1 hour. 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 the components of ZERBAXA
(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 2 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 (ceftolozane and tazobactam) in the absence of a proven or
strongly suspected bacterial infection or a prophylactic indication
is unlikely to provide benefit to the patient and risks the
development of drug-resistant bacteria.
Adverse Reactions: The most common adverse reactions
occurring in ≥5% of patients. in the HABP/VABP trial were increase
in hepatic transaminases (11.9%), renal impairment/renal failure
(8.9%) and diarrhea (6.4%).
Merck’s Commitment to Infectious Diseases
For more than 100 years, Merck has contributed to the discovery
and development of novel medicines and vaccines to combat
infectious diseases. In addition to a combined portfolio of
vaccines and antibacterial, antiviral and antifungal medicines,
Merck has multiple programs that span discovery through late-stage
development. To learn more about Merck’s infectious diseases
pipeline, visit www.merck.com.
About Merck
For more than a century, Merck, a leading global
biopharmaceutical company known as MSD outside of the United States
and Canada, has been inventing for life, bringing forward medicines
and vaccines for many of the world's most challenging diseases.
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 health care
through far-reaching policies, programs and partnerships. Today,
Merck continues to be at the forefront of research to advance the
prevention and treatment of diseases that threaten people and
communities around the world - including cancer, cardio-metabolic
diseases, emerging animal diseases, Alzheimer's disease and
infectious diseases including HIV and Ebola. For more information,
visit www.merck.com and connect with us on Twitter, Facebook,
Instagram, YouTube and LinkedIn.
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 2018
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
https://www.merck.com/product/usa/pi_circulars/z/zerbaxa/zerbaxa_pi.pdf
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