10 June 2019
Merck Animal Health Publishes Real-World Data on BRAVECTO® (fluralaner)
Demonstrates longer-lasting flea and tick protection that is preferred by 82 to 92 percent of dog owners across three countries
Demonstrates improved adherence to treatment recommendations
MADISON, N.J., June 10, 2019 – Merck Animal Health, a division of Merck & Co., Inc., Kenilworth, N.J., USA, today announced significant, global real-world data that support and reinforce the benefits of BRAVECTO® (fluralaner), the only nose to toes flea and tick treatment that provides up to 12 weeks of protection for dogs. Fleas and ticks are not just a nuisance, but also pose animal and human health risks, as they can transmit diseases such as Lyme disease, Babesiosis and Bartonellosis.
Six comprehensive studies recently published in peer-reviewed veterinary journals and one soon-to-be-published study support the benefits of longer-lasting flea and tick protection. The data evaluated the positive impact of extended duration flea and tick control in the U.S., U.K., Australia, Spain and South Africa, and measured the increase in adherence to veterinary recommendations that accompanies the extended duration of action.
“These studies show that, by using a longer-acting flea and tick product, dog owners are more likely to keep their dogs protected from fleas and ticks for more months of the year, and are more likely to follow their veterinarian’s recommendation of using flea and tick product year-round,” said Robert P. Lavan, DVM, MPVM, DACVPM, Director, Outcomes Research, Center for Observational and Real-World Evidence at Merck Animal Health. “Furthermore, when compared to monthly flea and tick products, dog owners preferred BRAVECTO and reported the convenience of less-frequent dosing as a key benefit of extended duration flea and tick control.”
Dogs owners using longer-lasting BRAVECTO adhered better to veterinarian flea and tick treatment recommendations, providing their dogs with more months of flea and tick protection
In flea and tick control, pet owner adherence to treatment recommendations is critical for medication effectiveness, and lack of adherence is thought to be a common cause of treatment failure.
In a study of 25 veterinary practices in the U.S. from April to June 2016, 559 dog owners completed a survey about their experience with BRAVECTO and monthly flea and tick medications. The results of the survey found that nearly 90 percent of dog owners (89%) preferred BRAVECTO vs. monthly medications. Respondents identified convenience (74%), the 12-week dosing interval (69%), and less-frequent dosing (68%) as the three most important benefits of using BRAVECTO.i An additional two surveys were conducted to evaluate the responses of dog owners in the UK and Australia regarding their flea and tick treatment preferences and to compare the results across the three countries; the results are soon-to-be-published in a major veterinary journal. In the analysis of responses from 1,608 dog owners across the three countries, preference for BRAVECTO vs. monthly medications was uniformly high (89% U.S., 92% UK, 82% Australia). Dog owners also reported high satisfaction (93-96%) with the extended duration flea and tick product. Furthermore, most participating dog owners thought that they were more likely to give the follow-up doses on time for fluralaner compared to monthly products (65% U.S., 74% UK, 63% Australia).ii
A cross-sectional study of 24 veterinary hospitals in the U.S., published in Parasites & Vectors, found that while almost all veterinary hospitals recommended 12 months of flea and tick prevention, only 62 percent of dog owners recalled this recommendation.iii
“This study demonstrates that pet owner flea and tick treatment adherence falls short of veterinarians’ recommendations, and we have work to do to help people control these pests,” said Rob Armstrong, DVM, DVSc, Director, Scientific Affairs, Merck Animal Health. “Treatments that protect for a longer period contribute to improved adherence to treatment recommendations. For example, BRAVECTO provides coverage for a year with about four doses vs. 12 doses for monthly products.”
In other separate studies published in Parasites & Vectors based on analysis of veterinary records from clinics in the U.S. and Spain, dog owners who used BRAVECTO were significantly more likely to obtain more months of flea and tick protection compared with dog owners who purchased monthly treatments.
In the U.S., dog owners who used BRAVECTO achieved significantly more months of flea/tick protection (5.7 months) over the 12-month study period than dog owners who used monthly treatments (3.3 to 4.6 months). This translates into a gain in the average duration of protection of up to 73 percent with BRAVECTO over the monthly treatments in the U.S.iv
In Spain, close to double the number of dog owners achieved seven to 12 months of protection when they were prescribed BRAVECTO (15.7%) by their veterinarians compared with dog owners prescribed monthly flea and tick products (6.8 to 8.3%). Dog owners prescribed BRAVECTO achieved 4.3 months of protection per year, significantly more months of coverage than those prescribed monthly products (2.9 to 3.2 months per year). This translates into a gain in the average duration of flea and tick protection of up to 50 percent with BRAVECTO over the monthly treatments in Spain.v
Different heartworm medication-dosing intervals did not negatively impact use of this medication in U.S. dogs
In a comparative analysis published in Parasites & Vectors of heartworm medication purchases in the U.S. for over 200,000 dogs at 650 veterinary clinics from 2014 to 2017, dog owners who used BRAVECTO also adhered to veterinary recommendations for heartworm protection.vi
“Since heartworm medication is dosed monthly, we evaluated the impact of the use of BRAVECTO, which is dosed at 12-week intervals, on the use of heartworm medication,” said Dr. Lavan. “In this study, we were encouraged to learn that dogs that received BRAVECTO or monthly flea and tick medications all had about seven months of heartworm medication use and that the different dosing intervals of flea and tick medication had no effect on the dosing adherence of heartworm prevention medications.”
Reduction in tick-borne disease observed after introduction of BRAVECTO
In a study published in Parasites & Vectors of medical records from veterinary hospitals in South Africa from 2011-2016, veterinarians reported a multi-year decline in dogs with babesiosis, a common and serious tick-borne disease that can cause weakness, anemia and jaundice and affect multiple organ systems. Among 44 veterinary hospitals across South Africa, the absolute number of canine babesiosis treatments administered declined by 46 percent from 2011 to 2016, and the overall calculated healthcare use rate declined 72 percent. The steepest annual decline of 31 percent in the canine babesiosis healthcare use rate was observed between 2015 and 2016, after the introduction of BRAVECTO. There were no other new classes of tick products for dogs introduced during this period.vii
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.viii
Providing pets with continuous flea and tick protection is essential – whether the pet goes outside or not. Contrary to popular belief among pet parents, 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.
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 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 [http://www.us.bravecto.com].