Merck Animal Health Receives U.S. FDA Approval of BRAVECTO® (fluralaner) Monthly Chews

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July 9, 2020 4:30 pm ET

Portfolio Expansion Ensures Dogs and Puppies 8 Weeks of Age and Older Receive Early, Broad-Spectrum Protection Against Fleas and Ticks

MADISON, N.J.--(BUSINESS WIRE)-- 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 TheScience 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.