MSD Animal Health Receives Positive Opinion from European Medicines Agency for BRAVECTO® Plus (fluralaner plus moxidectin) Spot-on Solution for Cats
MSD Animal Health (known as Merck Animal Health in the United States and Canada) today announced that the Committee for Medicinal Products for Veterinary Use (CVMP) of the European Medicines Agency 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.
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, known as Merck Animal Health in the United States and Canada, 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 range of veterinary pharmaceuticals, vaccines and health management solutions and services. MSD Animal Health is dedicated to preserving and improving the health, well-being and performance of animals. 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.
Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA
This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.
Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.
The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s 2017 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).
Gail S. Thornton, + 1 973-937-5453
Marco Gassen, +49 89 456 14202
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Michael DeCarbo, + 1 908-740-1807
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