Merck Animal Health Receives Positive CVMP Opinion for an Injectable Formulation of BRAVECTO® (Fluralaner) for Use in Dogs

Merck Animal Health Receives Positive CVMP Opinion for an Injectable Formulation of BRAVECTO® (Fluralaner) for Use in Dogs




Merck Animal Health Receives Positive CVMP Opinion for an Injectable Formulation of BRAVECTO® (Fluralaner) for Use in Dogs

RAHWAY, N.J.–(BUSINESS WIRE)–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 that the European Medicines Agency’s Committee for Veterinary Medicinal Products (CVMP) issued a positive opinion for BRAVECTO® (fluralaner) 150 mg/ml powder and solvent for suspension for injection for dogs. The CVMP recommends the product for approval for the treatment and persistent killing of fleas (Ctenocephalides felis and Ctenocephalides canis) and ticks (Rhipicephalus sanguineus, Ixodes ricinus, Ixodes hexagonus, and Dermacentor reticulatus) for 12 months. If the European Commission (EC) adopts the recommendation, this injectable formulation of BRAVECTO can be used by or under the supervision of a veterinarian and for administration to dogs and puppies six months of age and older.


“Since our initial launch of BRAVECTO nearly a decade ago, Merck Animal Health has been committed to bringing innovations to our customers that protect pets longer from flea and tick infestations and the associated health risks,” said Rick DeLuca, executive vice president and president, Merck Animal Health. “With today’s positive opinion of this injectable formulation of BRAVECTO, the first and only once-yearly injectable flea and tick medication, pet owners are one step closer to a new, convenient option to help ensure year-round comprehensive protection from fleas and ticks without the need for administering multiple doses of medication.”

Certain ticks can transmit serious infections in dogs. Many ticks can live in both warm and cold temperatures and are known to feed on dogs,1 making continuous year-round protection of utmost importance for pets and people.

“Though people often think of flea and tick season during the summer months, studies have shown that while fleas and ticks are most active from early spring through the fall, they can be a threat year-round,” said Holger Lehmann, vice president, Pharmaceutical Research & Development, Merck Animal Health. “If approved, a once-yearly dosing of BRAVECTO injectable can provide a long duration of protection, simplifying care for both pet owners and veterinarians. This promotes compliance and helps ensure continuous protection.”

Based on the CVMP’s recommendation, the EC is expected to issue a decision for marketing authorization in the European Union (EU) during the first quarter of 2024.

About BRAVECTO® (fluralaner)

Since its introduction in 2014, BRAVECTO has provided longer-lasting flea and tick protection, with more than 300 million doses distributed in more than 100 countries. BRAVECTO is available in a variety of formulations, including products for both dogs and cats.

The flea and tick life cycles can also last for months and missed doses of 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 parents, fleas and ticks are not only active in the spring and summer months, but they are a year-round risk.

Fleas and ticks can easily infest dogs and cats. They also can bite and pose health risks to human family members whether at home or outdoors. Ticks can spread serious diseases including rickettsiosis, anaplasmosis and borreliosis (Lyme disease), while fleas are the most common external parasite found on pets and can transmit bartonellosis (Cat Scratch disease) and tapeworms.

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, producers, 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, X (Formerly 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. There can be no guarantees with respect to pipeline candidates that the candidates 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 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, 2022 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

References

[1] Probst J, Springer A, Topp AK, Bröker M, Williams H, Dautel H, Kahl O, Strube C. Winter activity of questing ticks (Ixodes ricinus and Dermacentor reticulatus) in Germany− Evidence from quasi-natural tick plots, field studies and a tick submission study. Ticks and Tick-borne Diseases. 2023 Nov 1;14(6):102225.

Contacts

Media:

Kim Gorode

(973) 255-8904

Kim.Gorode@merck.com

Investor:

Peter Dannenbaum

(732) 594-1579