13 August 2019

MSD Animal Health Receives Marketing Authorization from European Commission for Additional Indication of BRAVECTO® Plus (fluralaner plus moxidectin) for Cats

Spot-on solution now indicated for the treatment of ear mite infestations, in addition to ticks and fleas, heartworm, roundworm and hookworm

MADISON, N.J., August 13, 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 an additional indication of a marketing authorization for the veterinary medicinal product BRAVECTO® Plus (fluralaner plus moxidectin), a spot-on solution for cats. The new therapeutic indication is for the treatment of infestations with ear mites (Otodectes cynotis). BRAVECTO® Plus is also indicated for mixed parasitic infestations by ticks and fleas, gastrointestinal nematodes or heartworm.

Ear mites (Otodectes cynotis) are highly transmissible parasites in the ear, causing cats significant discomfort through irritation that leads to frequent ear scratching, head shaking, inflammation and pain. Ear mites are the second most common external parasites on cats after fleas. Studies show topical application to the skin with BRAVECTO® Plus completely eliminated ear mites from infested cats with one dose, resulting in no visible mites at 14 days and 100% efficacy confirmed at 28 days. Further veterinary examination, such as an otoscopy, is recommended 28 days after the treatment.

With the additional indication, BRAVECTO® Plus is a long-acting, broad-spectrum combination topical solution for cats with, or at risk from, both internal and external parasite infestations: ticks and fleas, heartworm, roundworm, hookworm and ear mites.

Details of the product are described in the updated Summary of Product Characteristics (SPC). Please see updated SPC at https://www.ema.europa.eu/en/documents/product-information/bravecto-plus-epar-product-information_en.pdf.

About BRAVECTO® Plus

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, hookworm and ear mites. 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. Since its introduction, more than 100 million doses have been distributed in 85 countries over five years.

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.