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

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.


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