FDA approves NexGard® (afoxolaner) for the prevention of infections that cause Lyme disease in dogs

First, and only, flea and tick product approved by the FDA to prevent Borrelia burgdorferi infections in dogs by killing black-legged ticks.

News provided by

Boehringer Ingelheim

Aug 27, 2018, 11:48 ET

DULUTH, Ga., Aug. 27, 2018 /PRNewswire/ -- Merial, now part of Boehringer Ingelheim, received approval from the U.S Food and Drug Administration (FDA) to expand the label claims for NexGard (afoxolaner), the chewable flea and tick product that is preferred by dogs.¹The product is now approved to prevent Borrelia burgdorferi infections by killing Ixodes scapularis ticks (commonly referred to as black-legged ticks or deer ticks), vectors that transmit the bacterium that causes Lyme disease.

Lyme disease is a significant threat to dogs in many parts of the country. To reduce the risk of Lyme disease and the ticks that transmit it, pet owners should consider utilizing a multimodal approach. This may include avoiding areas with high tick burdens and taking steps to reduce the number of ticks in their surroundings. Pets should be checked daily for ticks, and any ticks found should be removed. Pet owners can also consult with their veterinarians to determine if their dogs should receive a Lyme vaccination. Veterinary experts also recommend year-round tick control for all dogs.

NexGard is the first, and only, flea and tick product to receive FDA approval for preventing infections that cause Lyme disease by killing the vector ticks. The approval comes just as veterinarians and pet owners in many parts of the country are being warned about the potential of an increased number of Lyme disease cases in 2018.²

"When NexGard, an easy-to-give, beef-flavored chew, was launched in 2013, it was the first oral flea and tick control product and the first of the isoxazoline class of parasiticides," said Zach Mills, DVM, Head of US Pet Veterinary Professional Services. "As Boehringer Ingelheim continues to make advancements in veterinary medicine with a focus on prevention, having the first flea and tick product approved to prevent the transmission of the organism that causes Lyme disease is evidence of our commitment to do just that."

The FDA approval is based on two well-controlled laboratory studies, which showed that NexGard effectively prevented the transmission of Borrelia burgdorferi infections after dogs were infested with wild-caught Ixodes scapularis ticks 28 days after treatment with NexGard.

"Both studies measured the transmission of B. burgdorferi to dogs after exposure to infected ticks. All dogs treated with NexGard tested negative for B. burgdorferi infection, demonstrating that transmission was prevented as a direct result of NexGard killing infected ticks," said Dr. Mills. "This research shows that NexGard provides a full month of protection against black-legged ticks infected with the bacterium that causes Lyme disease."

In addition to killing black-legged ticks, NexGard also kills Lone star ticks, American dog ticks and brown dog ticks. It also prevents flea infestations by killing adult fleas before they lay eggs. NexGard remains veterinarians' top choice for flea and tick protection in dogs.³

To learn more about NexGard, visit NexGardForDogs.com or contact your veterinarian.

IMPORTANT SAFETY INFORMATION
NexGard is for use in dogs only. The most frequently reported adverse reactions include vomiting, pruritus, lethargy, diarrhea, and lack of appetite. The safe use of NexGard in pregnant, breeding, or lactating dogs has not been evaluated. Use with caution in dogs with a history of seizures or neurologic disorders. For more information, click here for full prescribing information or visit www.NexGardForDogs.com.

About Boehringer Ingelheim Animal Health
Boehringer Ingelheim is the second largest animal health business in the world. The company is committed to creating animal wellbeing through its large portfolio of advanced, preventive healthcare products and services. With net sales of €3.9 billion and around 10,000 employees worldwide, Boehringer Ingelheim's Animal Health business is present in more than 150 markets. For more information, click here.

About Boehringer Ingelheim
Boehringer Ingelheim is one of the world's top 20 pharmaceutical companies. Headquartered in Ingelheim, Germany, the company operates globally with approximately 50,000 employees. Since its founding in 1885, the company has remained family-owned and today creates value through innovation in three business areas including human pharmaceuticals, animal health and biopharmaceutical contract manufacturing. Boehringer Ingelheim is committed to improving lives and providing valuable services and support to patients and their families. In 2017, Boehringer Ingelheim achieved net sales of about $20.4 billion (18.1 billion euros). R&D expenditure corresponds to approximately $3.4 billion (three billion euros), or 17.0 percent of its net sales.

More information about Boehringer Ingelheim can be found on www.boehringer-ingelheim.com or in our annual report: http://annualreport.boehringer-ingelheim.com.

References:
¹ Data on file at Merial.
²"Dogs continue to be at an elevated risk of heartworm and Lyme disease in 2018" Companion Animal Parasite Council. Accessed July 18, 2018. http://www.petsandparasites.org/expert-insights/dogs-continue-to-be-at-an-elevated-risk-of-heartworm-disease-and-lyme-disea
³ Data on file at Merial.

NexGard is a Merial product. Merial is now part of Boehringer Ingelheim.

NexGard^® is a registered trademark of Merial.
©2018 Merial, Inc., Duluth, GA. All rights reserved. PET-0679-NEX0818

SOURCE Boehringer Ingelheim