Merck Receives FDA Approval for ZINPLAVA™

- October 21st, 2016

Merck today announced that the U.S. Food and Drug Administration (FDA) has approved ZINPLAVA™ (bezlotoxumab) Injection 25 mg/mL.

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
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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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