Sanofi announced that its animal health division Merial has received the US Food and Drug Administration (FDA) approval for NexGard (afoxolaner) chewables for the treatment and prevention of flea infestations, and treatment and control of the American Dog tick in adult dogs and puppies, for one month.

“We are pleased to announce the FDA approval of NexGard as a new option for veterinarians,” said Carsten Hellmann, CEO of Merial. “Merial is a market leader for parasiticide products, and we have leveraged that expertise as well as our strength in chewable technologies to develop NexGard. Being on the forefront of developing innovative new products also shows our commitment to the veterinary community.”

NexGard, which has demonstrated excellent efficacy at low dose, is the first and only soft beefflavored  chew approved to kill both fleas and ticks. It contains the novel active ingredient afoxolaner, an isoxazoline based compound with a new and distinct mode of action. NexGard was developed in four years from proof of concept by Merial R&D centres in The United States and Europe.

NexGard will be a prescription-only product. It will be available in four sizes for oral administration to dogs and puppies according to weight.  Merial is planning to make NexGard available to veterinarians in time for the upcoming flea and tick season.

Merial already markets Frontline, a topical flea and tick control product for dogs and cats, which is the best-selling veterinary product in the world. The addition of NexGard is a significant milestone in complementing Merial’s existing product portfolio and strengthening its companion animal offerings.

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.

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.