Merck (NYSE:MRK), known as MSD outside the United States and
Canada, today announced that the U.S. Food and Drug Administration
(FDA) has approved ZINPLAVA™ (bezlotoxumab) Injection 25 mg/mL.
Merck anticipates making ZINPLAVA available in first quarter
2017.
ZINPLAVA is indicated to reduce recurrence of Clostridium
difficile infection (CDI) in patients 18 years of age or older who
are receiving antibacterial drug treatment of CDI and are at high
risk for CDI recurrence. ZINPLAVA is not indicated for the
treatment of CDI. ZINPLAVA is not an antibacterial drug. ZINPLAVA
should only be used in conjunction with antibacterial drug
treatment of CDI.
CDI is caused by bacteria that produce toxins, including toxin
B. Symptoms of CDI include mild-to-severe diarrhea, abdominal pain
and fever. The incidence of recurrent CDI is higher in certain
patient populations, including people 65 years of age or older and
those with compromised immune systems.
“For generations, Merck has been steadfast in its commitment to
fighting infectious diseases – and that commitment continues today.
ZINPLAVA is a human monoclonal antibody that binds to C. difficile
toxin B and neutralizes its effects,” said Dr. Nicholas Kartsonis,
vice president of clinical development, infectious diseases, Merck
Research Laboratories.
Selected safety information about ZINPLAVA
Heart failure was reported more commonly in the two Phase 3
clinical trials in ZINPLAVA-treated patients compared to
placebo-treated patients. These adverse reactions occurred
primarily in patients with underlying congestive heart failure
(CHF). In patients with a history of CHF, 12.7% (15/118) of
ZINPLAVA-treated patients and 4.8% (5/104) of placebo-treated
patients had the serious adverse reaction of heart failure during
the 12-week study period. Additionally, in patients with a history
of CHF, there were more deaths in ZINPLAVA-treated patients [19.5%
(23/118)] than in placebo-treated patients [12.5% (13/104)] during
the 12-week study period. The causes of death varied, and included
cardiac failure, infections, and respiratory failure. In patients
with a history of CHF, ZINPLAVA (bezlotoxumab) should be reserved
for use when the benefit outweighs the risk.
The most common adverse reactions occurring within 4 weeks of
infusion with a frequency greater than placebo and reported in ≥4%
of patients treated with ZINPLAVA and Standard of Care (SoC)
antibacterial drug therapy vs placebo and SoC antibacterial drug
therapy included nausea (7% vs 5%), pyrexia (5% vs 3%) and headache
(4% vs 3%).
Serious adverse reactions occurring within 12 weeks following
infusion were reported in 29% of ZINPLAVA-treated patients and 33%
of placebo-treated patients. Heart failure was reported as a
serious adverse reaction in 2.3% of ZINPLAVA-treated patients and
1.0% of placebo-treated patients.
In ZINPLAVA-treated patients, 10% experienced one or more
infusion specific adverse reactions compared to 8% of
placebo-treated patients, on the day of or the day after, the
infusion. Infusion specific adverse reactions reported in ≥0.5% of
patients receiving ZINPLAVA and at a frequency greater than placebo
were nausea (3%), fatigue (1%), pyrexia (1%), dizziness (1%),
headache (2%), dyspnea (1%) and hypertension (1%). Of these
patients, 78% experienced mild adverse reactions, and 20% of
patients experienced moderate adverse reactions. These reactions
resolved within 24 hours following onset.
As with all therapeutic proteins, there is a potential for
immunogenicity following administration of ZINPLAVA. The detection
of antibody formation is highly dependent on the sensitivity and
specificity of the assay. Additionally, the observed incidence of
antibody (including neutralizing antibody) positivity in an assay
may be influenced by several factors including assay methodology,
sample handling, timing of sample collection, concomitant
medications, and underlying disease. For these reasons, comparison
of the incidence of antibodies to bezlotoxumab in two Phase 3
studies with the incidence of antibodies in other studies or to
other products may be misleading. Following treatment with ZINPLAVA
in these two studies, none of the 710 evaluable patients tested
positive for treatment-emergent anti-bezlotoxumab antibodies.
About bezlotoxumab
Bezlotoxumab was developed by researchers at the University of
Massachusetts Medical School’s MassBiologics Laboratory in
conjunction with Medarex (now part of Bristol-Myers Squibb), and
was licensed to Merck in 2009.
About Merck
For 125 years, Merck has been a global health care leader
working to help the world be well. Merck is known as MSD outside
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 health care through far-reaching policies,
programs and partnerships. For more information, visit
www.merck.com and connect with us on Twitter, Facebook, 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 2015
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 ZINPLAVA
(bezlotoxumab) at
http://www.merck.com/product/usa/pi_circulars/z/zinplava/zinplava_pi.pdf
and
Patient Information for ZINPLAVA at
http://www.merck.com/product/usa/pi_circulars/z/zinplava/zinplava_ppi.pdf
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version on businesswire.com: http://www.businesswire.com/news/home/20161021005977/en/
MerckMedia:Pamela Eisele, 267-305-3558orRobert Consalvo,
908-236-1127orInvestors:Teri Loxam, 908-740-1986orAmy Klug,
908-740-1898
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