25 November 2019

MSD Animal Health Receives European Marketing Authorization for Additional Indications of BRAVECTO® (fluralaner) to Treat Harmful Mite Infestations in Dogs

BRAVECTO® now indicated for treating dogs infested with Demodex canis and Sarcoptes scabiei var. canismites.

MADISON, N.J., November 25, 2019 – MSD Animal Health, a division of Merck & Co., Inc., Kenilworth, N.J., USA, today announced that following a positive opinion from the Committee for Medicinal Products for Veterinary Use (CVMP), the European Commission has granted two additional indications of a marketing authorization for the veterinary medicinal product BRAVECTO® (fluralaner) Chew and BRAVECTO® Spot-On for dogs.

The new therapeutic indications are for the treatment of demodectic (Demodex canis) mites and sarcoptic (Sarcoptes scabiei var. canis) infestations with BRAVECTO® Chew and Spot-On for dogs. BRAVECTO® Chew and Spot-On are also indicated for protection against flea and tick infestations in dogs, and can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD).

Demodex canis mites, which live in the hair follicles and sebaceous glands in the skin of dogs, can multiply rapidly and cause severe crusting and secondary infections. Infestation causes demodicosis, a skin disease characterized by scabs and infection, hair loss and red skin. A single administration of Bravecto chewable tablets or a single application of Bravecto spot-on solution, both at the currently approved dose is effective for the treatment of demodicosis caused by Demodex canis in dogs.i

Sarcoptes scabiei var. canismites burrow into the top layer of a dog’s skin, causing intense itching that can lead to skin infections. Infestation is called scabies mange and is a highly contagious skin disease characterized by hair loss, skin irritation and crusting. A single administration of Bravecto chewable tablets or a single application of Bravecto spot-on solution at the currently approved dose is effective in the treatment of sarcoptic mange (caused by Sarcoptes scabiei) in dogs, with elimination of live mite infestation and reduction in clinical signs.ii

Details of the product will be described in the Summary of Product Characteristics (SPC) posted by the European Medicines Agency.

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 Chew and Spot-On, including products for both dogs and cats.

Providing pets with continuous flea and tick protection all year round is essential – whether the pet goes outside or not. 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.

About MSD Animal Health

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, a division of Merck & Co., Inc., Kenilworth, N.J., USA, is the global animal health business unit of MSD. Through its commitment to the Science of Healthier Animals®, MSD 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. MSD 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. MSD Animal Health is present in more than 50 countries, while its products are available in some 150 markets. For more information, visit www.msd-animal-health.com/ or connect with us on LinkedIn and Twitter.

iCVMP assessment report for Bravecto (EMEA/V/C/002526/II/0036)

iiCVMP assessment report for Bravecto (EMEA/V/C/002526/II/0033/G)