Merial Announces EU Approval For NexGard®

February 19, 2014 /3BL Media/ - Sanofi and its animal health division, Merial, today announced that the European Commission has approved NexGard® (afoxolaner) for the treatment of flea and tick infestations in dogs. One oral treatment kills fleas for at least 5 weeks and ticks for up to one month. NexGard can also be used as part of a treatment strategy for the control of Flea Allergy Dermatitis (FAD)1.

"The NexGard approval in Europe, less than 6 months after receiving US FDA approval, is an important milestone for MeriaI and strengthens our parasiticides portfolio for companion animals. It provides an additional, truly innovative treatment option to our veterinary customers, demonstrating why Merial is a global market leader in pet parasiticides and at the forefront of developing new technologies. In this case with a tasty and easy to use product that supports adherence by being a positive experience for both the dog and its owner" said Carsten Hellmann, Merial’s CEO. "We have just started roll-out in the US and can now launch in Europe and other regions in the world. This global launch of a novel, innovative oral product supports the future growth of Merial".

The novel active ingredient in NexGard, afoxolaner, is a compound from the isoxazoline family, with a new and distinct mode of action. It acts as an ‘ectoparasiticide’, which means that it kills parasites, such as fleas and ticks, which live on the skin or in the fur of animals. NexGard kills fleas fast, before they can lay eggs, and provides lasting protection against ticks.

Fleas and ticks can be a serious health issue for pets, and a preventive program that includes flea and tick control is an important component of responsible pet care. NexGard is the first and only monthly, beef-flavored chew for the treatment of flea and tick infestations in adult dogs and puppies eight weeks of age or older, weighing two kilograms or more.

Studies showed that NexGard was effective in treating infestations by the main species of fleas and ticks in dogs. According to the studies, NexGard is highly palatable, with 90 percent of dogs readily accepting the chew2. NexGard is well tolerated when administered at the recommended treatment dose. Mild adverse events (gastrointestinal effects) were only observed at several multiples of the recommended dose. It will be available by veterinarian prescription only.

References

1. NexGard Summary of Product Characteristics.

2. NexGard European Public Assessment Report, EMA  

About Merial

Merial is a world-leading, innovation-driven animal health company, providing a comprehensive range of products to enhance the health, well-being and performance of a wide range of animals. Merial employs around 6,200 people and operates in more than 150 countries worldwide with close to €2 billion of sales. Merial is a Sanofi company. www.merial.com

About Sanofi

Sanofi, an integrated global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).