Portfolio expansion provides dogs
broad-spectrum protection against Asian longhorned
ticks
Merck Animal Health, known as MSD Animal Health outside of the
United States and Canada, a division of Merck & Co., Inc.,
Rahway, N.J., USA (NYSE:MRK), today announced the U.S. Food and
Drug Administration’s approval of an expanded indication for
BRAVECTO® Chews for Dogs. The new indication treats and controls
Asian longhorned ticks, which are an invasive Ixodid species
located across more than one-third of the U.S1,2.
BRAVECTO Chews for Dogs is the first and only U.S. product
labeled for the treatment and control of Asian longhorned tick
infestations. These ticks have the potential to quickly become an
important tick species within pet populations and have been known
to carry various viral, bacterial and protozoal agents. This
product label expansion is an important addition to the company’s
BRAVECTO product portfolio, which are extended duration flea and
tick protection products that offer broad-spectrum, comprehensive
parasite protection for dogs.
“The approval of this additional BRAVECTO use builds on the
strong foundation and body of scientific evidence that we have
established over the years with our broad-spectrum comprehensive
line of parasite protection products,” said Holger Lehmann, DVM,
PhD, vice president, Pharmaceutical Research and Development, Merck
Animal Health. “With BRAVECTO’s new indication in Asian longhorned
ticks, we have expanded our portfolio with an important claim in
the fight against parasites, as well as provided dogs with flea and
tick protection that delivers immediate and persistent killing
activity.”
BRAVECTO Chews for dogs is indicated for the treatment and
prevention of flea infestations (Ctenocephalides felis), treatment
and control of tick infestations (Ixodes scapularis (black-legged
tick), Dermacentor variabilis (American dog tick), Rhipicephalus
sanguineus (brown dog tick)] and Haemaphysalis longicornis (Asian
longhorned tick) for 12 weeks and treatment and control of
Amblyomma americanum (lone star tick) infestations for 8 weeks.
“Parasites pose serious animal and human health risks as fleas
and ticks can transmit disease agents,” said Kathryn Duncan, DVM,
PhD, DACVM, parasitology field specialist, Merck Animal Health.
“Protection against the Asian longhorned tick is critical because
its prevalence is increasing throughout the country. This expanded
indication from Merck Animal Health represents a scientific
milestone in our continued commitment to providing the highest
level of proven treatments in battling parasites faced by our
pets.”
BRAVECTO Chews for Dogs is part of the Merck Animal Health
Companion Animal portfolio, which includes a broad range of
veterinary medicines and vaccines, as well as the SURE PETCARE™
brand platform of digitally connected products along with the
HomeAgain® brand-leading service provider in pet recovery.
BRAVECTO Chews for Dogs is available in five strengths (112.5,
250, 500, 1000, and 1400 mg fluralaner) per chew. To learn more
about BRAVECTO and our innovative flea and tick treatments, visit
us.bravecto.com.
About BRAVECTO® Since its introduction in 2014, BRAVECTO
has provided longer-lasting flea and tick protection, with more
than 250 million doses distributed in 85 countries over eight
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. 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. Fleas are the most
common external parasite found on pets. BRAVECTO products are only
available through licensed veterinarians.
Important Safety Information BRAVECTO 1-MONTH Chews:
indicated for dogs 8 weeks of age and older. The most commonly
reported adverse reactions include itching, diarrhea, vomiting,
decreased appetite, elevated ALT, lethargy, and weight loss.
BRAVECTO 1-MONTH is not effective against A. americanum in puppies
less than 6 months of age. BRAVECTO Chews for Dogs: The most
commonly reported adverse reactions include vomiting, lethargy,
diarrhea, anorexia and pruritus. In some cases, adverse events have
been reported following use in breeding females. BRAVECTO Topical
Solution for Dogs: The most commonly reported adverse reactions
include vomiting, hair loss, diarrhea, lethargy, decreased
appetite, and moist dermatitis/rash. 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 Topical Solution
for Cats is not effective against American dog ticks beyond 8 weeks
of dosing. BRAVECTO PLUS Topical 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. 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 been evaluated.
BRAVECTO has not been shown to be effective for 12-weeks’
duration in puppies or kittens less than 6 months of age. BRAVECTO
Chews and Topical Solution for dogs is not effective against the
lone star tick beyond 8 weeks of dosing. BRAVECTO Topical Solution
for Dogs and Cats and BRAVECTO PLUS for cats are for topical use
only. Avoid oral ingestion. The safety of BRAVECTO Topical Solution
for Cats and BRAVECTO PLUS has not been established in breeding,
pregnant, and lactating cats.
All BRAVECTO products contain fluralaner, which is a member of
the isoxazoline class. This class has been associated with
neurologic adverse reactions including tremors, ataxia, and
seizures. Seizures have been reported in dogs receiving isoxazoline
class drugs, even in dogs without a history of seizures. Use with
caution in dogs with a history of seizures or neurologic disorders.
Neurologic adverse reactions have been reported in cats receiving
isoxazoline class drugs, even in cats without a history of
neurologic disorders. Use with caution in cats with a history of
neurologic disorders.
About Merck Animal Health At Merck, known as MSD outside
of the United States and Canada, we are unified around our purpose:
We use the power of leading-edge science to save and improve lives
around the world. For more than a century, we’ve been at the
forefront of research, bringing forward medicines, vaccines and
innovative health solutions for the world’s most challenging
diseases. Merck Animal Health, a division of Merck & Co., Inc.,
Rahway, N.J., USA, is the global animal health business 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 connected technology that includes
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 and connect with us on LinkedIn,
Facebook, Twitter and Instagram.
Forward-Looking Statement of Merck & Co., Inc., Rahway,
N.J., USA This news release of Merck & Co., Inc., Rahway,
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. 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 the global outbreak of novel coronavirus disease
(COVID-19); 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 Annual
Report on Form 10-K for the year ended December 31, 2021 and the
company’s other filings with the Securities and Exchange Commission
(SEC) available at the SEC’s Internet site (www.sec.gov).
___________________________________________
- Raghaven et al (Potential Spatial Distribution of the Newly
Introduced Long-horned Tick, Haemaphysalis longicornis in North
America).
- United States Department of Agriculture (USDA) National
Haemaphysalis longicornis (Asian longhorned tick) Situation
Report.
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version on businesswire.com: https://www.businesswire.com/news/home/20230126005331/en/
Media: Laurel Mundth +1 (908) 872-9783
laurel.mundth@merck.com
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