Portfolio Expansion Ensures Dogs and Puppies
8 Weeks of Age and Older Receive Early, Broad-Spectrum Protection
Against Fleas and Ticks
Merck Animal Health, known as MSD Animal Health outside the
United States and Canada, a division of Merck & Co., Inc.,
Kenilworth, N.J., USA, [NYSE: MRK], today announced the U.S. Food
and Drug Administration’s approval of BRAVECTO® 1-MONTH
(fluralaner) Chews for dogs and puppies 8 weeks of age and older.
The product is administered as a single, monthly flavored chew
formulation for treatment and prevention of fleas and treatment and
control of ticks. BRAVECTO 1-MONTH is expected to be available in
the coming months.
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Merck Animal Health Receives U.S. FDA
Approval of BRAVECTO® (fluralaner) Monthly Chews (Photo: Business
Wire)
BRAVECTO 1-MONTH is an important addition to the company’s
parasiticide portfolio, which are extended duration flea and tick
protection products that offer broad-spectrum, comprehensive
parasite protection for dogs. This new product is suitable for dogs
in the early stages of life to begin a regimen of monthly flea and
tick protection. Pet owners now can begin their dog’s early life
experience on this monthly product and have the option to easily
transition to the extended duration BRAVECTO products as the dog
reaches 6 months of age, helping to ensure consistent treatment and
compliance.
“The approval of this additional BRAVECTO product 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 KJ Varma, BVSc, PhD,
senior vice president, Research and Development, Merck Animal
Health. “With BRAVECTO 1-MONTH, we have expanded our portfolio with
a superior advance in the fight against parasites, as well as
provided both adult dogs and puppies with flea and tick protection
that delivers immediate and persistent killing activity.”
BRAVECTO 1-MONTH 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), Dermacentor variabilis (American
dog tick) and Rhipicephalus sanguineus (brown dog tick)] for one
month in dogs and puppies 8 weeks of age and older and weighing 4.4
pounds or greater. BRAVECTO 1-MONTH is also indicated for the
treatment and control of Amblyomma americanum (lone star tick)
infestations for one month in dogs and puppies 6 months of age and
older and weighing 4.4 pounds or greater.
“Parasites pose serious animal and human health risks as fleas
and ticks can transmit disease,” said Christine Royal, DVM,
executive director, U.S. Companion Animal and Equine Professional
Services, Merck Animal Health. “Effective protection against these
parasites is essential to safeguard our pets as well as our homes.
The approval of BRAVECTO 1-MONTH is an ideal start for dogs in the
early stages of life with the benefit of a tasty, monthly chew
formulation that is fast-acting and efficacious.”
BRAVECTO 1-MONTH contains fluralaner, an ectoparasiticide
belonging to the isoxazoline class, which has systemic activity
against ticks and fleas. The product is available in five strengths
(45, 100, 200, 400 and 560 mg) per chew.
BRAVECTO 1-MONTH is part of the Merck Animal Health companion
animal portfolio, which includes Sure Petcare, a range of digitally
connected products, as well as a broad range of veterinary
medicines and vaccines.
On July 2, 2020, Merck Animal Health announced the completion of
its product acquisition for the U.S. rights to SENTINEL® FLAVOR
TABS® and SENTINEL® SPECTRUM® Chews in the Companion Animal
category. Comprehensive parasite protection is an essential part of
canine overall health and well-being. The BRAVECTO product line,
which are our extended duration flea and tick protection products,
and the SENTINEL branded products, which control all common
intestinal parasites, provide broad-spectrum, year-round
comprehensive internal and external parasite protection for dogs.
These complementary products will cover the seven common, harmful
parasites that affect dogs inside and out by preventing ticks and
multiple stages of the flea lifecycle, including eggs and adult
fleas, as well as treating and controlling all common intestinal
parasites, including roundworms, hookworms, whipworms and tapeworms
and preventing heartworm disease.
About BRAVECTO® (fluralaner)
Since its introduction in 2014, BRAVECTO has provided
longer-lasting flea and tick protection with more than 125 million
doses distributed in 85 countries.
BRAVECTO is available in a variety of extended-duration
formulations, including products for both dogs and cats 6 months of
age or older, as one treatment with BRAVECTO lasts up to 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.i
BRAVECTO Chews and BRAVECTO Topical Solution for Dogs are
safe for pregnant, breeding and lactating dogs. Use with caution in
dogs with a history of seizures or neurologic disorders.
BRAVECTO Chews for Dogs: Side effects may include vomiting,
decreased appetite, diarrhea, lethargy, excessive thirst and
flatulence. BRAVECTO Topical Solution for Dogs: Side effects
may include vomiting, hair loss, diarrhea, lethargy, decreased
appetite, and moist dermatitis/rash. BRAVECTO Topical Solution
for Cats: Side effects may include vomiting, itching, diarrhea,
hair loss, decreased appetite, lethargy, and scabs/ulcerated
lesions. Use with caution in cats with a history of neurologic
disorders. BRAVECTO PLUS for Cats is for cats 6 months of
age or older. Side effects may include vomiting, hair loss,
itching, diarrhea, lethargy, dry skin, elevated ALT, and
hypersalivation. Use with caution in cats with a history of
neurologic disorders. Use with caution in cats that are heartworm
positive.
BRAVECTO products are only available through licensed
veterinarians.
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. For more information, visit
www.surepetcare.com.
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 at @MerckAH.
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 the recent 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 2019
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).
i 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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Merck Media Contacts: Pam Eisele + 1 (267) 305-3558
Pamela.Eisele@merck.com
Gail S. Thornton +1 (908) 392-3420 Gail.Thornton@merck.com
Merck Investor Contact: Michael DeCarbo + 1 (908) 740-1807
Michael.DeCarbo@merck.com
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