Extended Duration Formulation Ensures Cats
Receive Broad-Spectrum Parasite Coverage in One Topical
Application
Merck Animal Health, a division of Merck & Co., Inc.,
Kenilworth, N.J., USA (NYSE: MRK), today announced the U.S.
approval of BRAVECTO® PLUS topical solution for cats by the U.S.
Food and Drug Administration (FDA). BRAVECTO PLUS is an
extended-duration, broad-spectrum combination (fluralaner and
moxidectin) topical solution for cats, indicated for both external
and internal parasite infestations: ticks and fleas, heartworm,
intestinal roundworm and hookworm. This unique formula in BRAVECTO
PLUS provides extended protection for up to two months with just
one application, making it the only product on the market to
protect against this combination of parasites at a longer duration.
BRAVECTO PLUS is expected to be available in the coming months.
“BRAVECTO PLUS addresses five of the top parasite concerns among
veterinarians and cat owners, including ticks, fleas, heartworms,
roundworms and hookworms,” said Christine Royal, DVM, director,
Professional Services at Merck Animal Health. “These parasites are
not just a nuisance, but also pose animal and human health risks.
Ticks and fleas can transmit disease; and heartworm disease,
transmitted by mosquitoes, is a serious, progressive disease that
often goes undiagnosed in cats. We are pleased to offer cat owners
the latest innovation from the BRAVECTO family.”
“With BRAVECTO PLUS for cats, we have expanded our portfolio in
the fight against parasites by creating an extended duration
formulation, ensuring pets receive the broad-spectrum parasite
coverage,” Dr. Royal said.
BRAVECTO PLUS contains fluralaner (280 mg/mL), an
ectoparasiticide which has systemic activity against ticks and
fleas, and moxidectin (14 mg/mL), an endectocide which has systemic
activity against a range of external and internal parasites.
BRAVECTO PLUS treats fleas and ticks fast, killing 100 percent
of fleas and more than 99.7% of ticks in the first 12 hours after
the product is applied.1 This protection works quickly and lasts.
Additionally, roundworm is the most common feline intestinal
parasite, affecting up to 75% of cats, and is also effectively
treated with BRAVECTO PLUS.2 The quality of extended-duration
treatment with BRAVECTO PLUS helps to improve compliance among pet
owners, which may lead to healthier cats.3,4
BRAVECTO PLUS is part of the Merck Animal Health pet health
portfolio, which includes Sure Petcare, a range of digitally
connected products.
About BRAVECTO® PLUS
BRAVECTO® PLUS is indicated for the prevention of
heartworm disease caused by Dirofilaria immitis and for the
treatment of infections with intestinal roundworm (Toxocara cati;
4th stage larvae, immature adults and adults) and hookworm
(Ancylostoma tubaeforme; 4th stage larvae, immature adults and
adults). BRAVECTO PLUS kills adult fleas and is indicated for the
treatment and prevention of flea infestations (Ctenocephalides
felis) and the treatment and control of tick infestations (Ixodes
scapularis; black-legged tick) and Dermacentor variabilis;
(American dog tick)] for 2 months in cats and kittens 6 months of
age and older and weighing 2.6 lb. or greater.
About BRAVECTO® (fluralaner)
Since its introduction in 2014, BRAVECTO has provided
longer-lasting flea and tick protection, with more than 100 million
doses distributed in 85 countries over five years. BRAVECTO is
available in a variety of formulations, including products for both
dogs and cats.
The flea lifecycle can last as long as 12 weeks, and monthly
treatments may leave gaps in protection. One treatment with
BRAVECTO lasts 12 weeks, protects almost three times longer than
monthly treatments and is proven to kill fleas on dogs and cats and
to eliminate them from the home.5
Providing pets with continuous flea and tick protection is
essential – whether the pet goes outside or not. Contrary to
popular belief among pet owners, fleas and ticks are not only
active in the spring and summer months and are a year-round
risk.
Fleas and ticks can easily latch onto dogs and cats, and can
spread serious diseases, including tapeworms and Lyme disease. They
also can bite and pose health risks to human family members whether
at home or outdoors. Fleas are the most common external parasite
found on pets.
BRAVECTO products are only available through licensed
veterinarians.
BRAVECTO has not been shown to be effective for 12-weeks'
duration in puppies or kittens less than 6 months of age.
BRAVECTO Chew: The most commonly reported adverse reactions
include vomiting, decreased appetite, diarrhea, lethargy,
polydipsia and flatulence. BRAVECTO is not effective against lone
star ticks beyond 8 weeks of dosing. BRAVECTO Topical Solution
for Dogs: The most commonly reported adverse reactions include
vomiting, hair loss, diarrhea, lethargy, decreased appetite and
moist dermatitis/rash. BRAVECTO is not effective against lone star
ticks beyond 8 weeks of dosing. For topical use only. Avoid oral
ingestion. Use caution in dogs with a history of seizures. Seizures
have been reported in dogs receiving fluralaner, even in dogs
without a history of seizures. BRAVECTO Topical Solution for
Cats: The most commonly reported adverse reactions include
vomiting, itching, diarrhea, hair loss, decreased appetite,
lethargy and scabs/ulcerated lesions. BRAVECTO is not effective
against American dog ticks beyond 8 weeks of dosing. For topical
use only. Avoid oral ingestion. The safety of BRAVECTO has not been
established in breeding, pregnant and lactating cats. Use with
caution in cats with a history of neurologic abnormalities.
Neurologic abnormalities have been reported in cats receiving
BRAVECTO, even in cats without a history of neurologic
abnormalities.
Important Safety Information about BRAVECTO PLUS spot-on
solution for Cats
The most commonly reported adverse reactions include vomiting,
hair loss, itching, diarrhea, lethargy, dry skin, elevated ALT, and
hypersalivation. BRAVECTO PLUS has not been shown to be effective
for 2 months in kittens less than 6 months of age. For topical use
only. Avoid oral ingestion. The safety of BRAVECTO PLUS has not
been established in breeding, pregnant and lactating cats.
Fluralaner is a member of the isooxazoline class. This class has
been associated with neurologic adverse reactions including
tremors, ataxia, and seizures. Neurologic adverse reactions have
been reported in cats receiving isooxazoline class drugs, even in
cats without a history of neurologic disorders. Use with caution in
cats with a history of neurologic disorders. Use with caution in
cats that are heartworm positive. The effectiveness of BRAVECTO
PLUS to prevent heartworm disease after bathing or water immersion
has not be evaluated.
About Merck Animal Health
For more than a century, Merck, a leading global
biopharmaceutical company, has been inventing for life, bringing
forward medicines and vaccines for many of the world’s most
challenging diseases. Merck Animal Health, a division of Merck
& Co., Inc., Kenilworth, N.J., USA, is the global animal health
business unit of Merck. Through its commitment to The Science of
Healthier Animals®, Merck Animal Health offers veterinarians,
farmers, pet owners and governments one of the widest ranges of
veterinary pharmaceuticals, vaccines and health management
solutions and services as well as an extensive suite of digitally
connected identification, traceability and monitoring products.
Merck Animal Health is dedicated to preserving and improving the
health, well-being and performance of animals and the people who
care for them. It invests extensively in dynamic and comprehensive
R&D resources and a modern, global supply chain. Merck Animal
Health is present in more than 50 countries, while its products are
available in some 150 markets. For more information, visit
www.merck-animal-health.com or connect with us on LinkedIn,
Facebook and Twitter.
About Sure Petcare
Sure Petcare, the pet technology specialist, provides pet
products that empower owners to care for their pets in entirely new
ways. Founded in 2007, we have developed an award-winning range of
microchip-operated pet doors and feeders, which solve many problems
commonly experienced by pet owners. Sure Petcare, along with
HomeAgain, is a Companion Animal portfolio of digital products
within Merck Animal Health.
Recently in the United States, Sure Petcare launched the
SureFeed Microchip Pet Feeder Connect, the next generation of the
best-selling SureFeed Microchip Pet Feeder, which monitors the
eating behavior of pets. The smart feeder monitors how much and
when a pet eats, sending real-time updates directly to the pet
owner’s phone. The new product also features integrated scales,
which enable owners to provide accurate food portions to their pet
at every meal.
For more information, visit www.surepetcare.com.
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 BRAVECTO® at
www.us.bravecto.com.
____________________________
1
Bravecto Plus FOI, NADA 141-518. (Study
S15318-00).
2
Cornell University College of Veterinary
Medicine website. Gastrointestinal Parasites of Cats.
https://www.vet.cornell.edu/departments-centers-and-institutes/cornell-feline-health-center/health-information/feline-health-topics/gastrointestinal-parasites-cats.
Accessed July 9, 2019.
3
Lavan RP et al. Parasites & Vectors.
2017;10:284.
4
Lavan RP et al. Parasites & Vectors.
2018;11:493.
5
Williams et al. Fluralaner, a novel
isoxazoline, prevents flea (Ctenocephalides felis) reproduction in
vitro and in a simulated home environment. Parasites & Vectors
(2014) 7:275.
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version on businesswire.com: https://www.businesswire.com/news/home/20191115005027/en/
Media: Pam Eisele + 1 267-305-3558 Pamela.Eisele@merck.com
Tom Schad +1 913-667-5537 Thomas.Schad@merck.com
Investor: Michael DeCarbo + 1 908-740-1807
Michael.decarbo@merck.com
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