15 Dec 2023
European Medicines Agency issues positive opinion for MSD Animal Health’s Bravecto, which, if approved, would be “first and only once-yearly injectable flea and tick medication” for dogs.
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European regulators are on course to approve a novel injectable form of Bravecto that would cover dogs for fleas and ticks for a year.
The European Medicines Agency (EMA) has issued a positive opinion for MSD Animal Health’s novel injectable form of the fluralaner, which persistently kills fleas (Ctenocephalides felis and Ctenocephalides canis) and ticks (Rhipicephalus sanguineus, Ixodes ricinus, Ixodes hexagonus, and Dermacentor reticulatus) for 12 months.
MSD said it was working with various regulatory bodies, including in the UK, to make the injectable product available in markets around the world soon. It could not currently comment on UK timings.
If the European Commission adopts the EMA’s recommendations, the injectable formulation would be available to use in EU countries by or under the supervision of a vet for administration to dogs and puppies six months and older.
Rick DeLuca, executive vice-president and president of MSD Animal Health, said: “Since our initial launch of Bravecto nearly a decade ago, MSD 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.
“With the 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.”
The authorisation for the EU is expected in the first quarter of 2024.