EMA committee recommends marketing approval for MSD Animal Health's Bravecto Plus spot-on solution for cats
MSD Animal Health (known as Merck Animal Health in the United States and Canada) announced that the Committee for Medicinal Products for Veterinary Use (CVMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorization for the veterinary medicinal product Bravecto Plus (fluralaner plus moxidectin) spot-on solution for cats.
If granted marketing approval, Bravecto Plus will be a sustained, broad-spectrum combination topical solution for cats with, or at risk from, both internal and external parasite infestations: ticks and fleas, heartworm, roundworm and hookworm. Detailed conditions of the product will be described in the summary of product characteristics (SPC), which will be published in the European public assessment report (EPAR) after marketing authorization has been granted by the European Commission.
Bravecto Plus is designed for cats with, or at risk from, mixed parasitic infestations and is applied topically using the unique “Twist’n’Use” pipette design for ease of application.
Once applied, Bravecto Plus provides immediate and persistent tick (Ixodes ricinus) and flea (Ctenocephalides felis) killing activity for 12 weeks, prevents heartworm disease caused by Dirofilaria immitis for 8 weeks, and also treats roundworm and hookworm.
Ticks and fleas must attach to the treated animal and commence feeding in order to be exposed to the active substance. Bravecto Plus also can be used as part of a treatment strategy for flea allergy dermatitis (FAD).
In 2014, Bravecto was launched as a chewable tablet for dogs and, in 2016, Bravecto spot-on was launched as a topical solution for dogs and cats. More than 60 million doses of Bravecto have been distributed in 72 countries since its introduction.
For more than a century, MSD, a leading global biopharmaceutical company, has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases. MSD Animal Health, known as Merck Animal Health in the United States and Canada, is the global animal health business unit of MSD.