by Corporate Communications/August 29, 2023
Boehringer Ingelheim Receives FDA Approval for NexGard® (afoxolaner) New Label Indication for Treatment and Control of Asian Longhorned Tick Infestation in Dogs
- NexGard® (afoxolaner), the #1 dog-preferred oral flea and tick protection,1 now protects against Asian Longhorned tick (Haemaphysalis longicornis) in dogs
- The FDA also approved the addition of label language that NexGard® chews improve the clinical signs of flea allergy dermatitis (FAD) as a direct result of killing fleas
- Tasty beef-flavored soft chew, designed to be delicious for dogs and easy to give, now offers even more robust monthly protection against fleas and ticks
- Label expansion deepens the Boehringer Ingelheim Animal Health parasiticide portfolio — including #1 vet-recommended and #1 dog-preferred HEARTGARD® Plus (ivermectin/pyrantel),2,3 and recently-launched NexGard® COMBO (esafoxolaner, eprinomectin, and praziquantel topical solution) broad-spectrum parasite protection for cats
Duluth, Ga., August 29, 2023 – Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) has approved a new label indication for NexGard® (afoxolaner) for the treatment and control of Asian Longhorned tick (Haemaphysalis longicornis) infestations for one month in dogs and puppies 8 weeks of age and older and weighing 4 pounds or more. NexGard®, the #1 dog-preferred oral flea and tick protection,1 now offers dog owners even more robust flea and tick protection in a tasty, monthly beef-flavored soft chew.
“Parasites, such as fleas and ticks, cause local lesions and are potent vectors of disease so they are a threat for both animals and humans. The label expansion of NexGard® chews to include the Asian Longhorned tick, which is now a threat in the U.S., will help veterinarians in their fight to protect pets against parasites,” said Dean Dailey, DVM, Senior Associate Director, U.S. Pet Veterinary Technical Marketing at Boehringer Ingelheim Animal Health.
The FDA also approved the addition of label language that NexGard® chews improve the clinical signs of flea allergy dermatitis (FAD) as a direct result of killing fleas. This update was based on a real-world study showing improvement in erythema, alopecia, papules, scales, crusts, and excoriation in dogs with flea infestations and signs of FAD following treatment with NexGard® chews.
These NexGard® label expansions deepen the Boehringer Ingelheim Animal Health parasiticide portfolio — including #1 vet-recommended and #1 dog-preferred HEARTGARD® Plus,2,3 and recently-launched NexGard® COMBO topical solution for cats.
Protection against an emerging threat
Haemaphysalis longicornis is an invasive tick species endemic to East Asia but is now established in the United States. First recorded in New Jersey in 2017, H. longicornis has spread to several states on the eastern seaboard.4 The spread is so rapid because H. longicornis ticks are able to produce viable eggs without mating, which can also lead to extremely high tick burdens on individual hosts.
This tick species is a threat to domestic pets, humans, livestock and wild animals due to its ability to transmit several dangerous pathogens, which can significantly harm the health and wellbeing of hosts.4,5
In addition to Asian Longhorned tick protection, NexGard® chews are already approved for the treatment and prevention of flea infestations (Ctenocephalides felis), and the treatment and control of Black-legged tick (Ixodes scapularis), American Dog tick (Dermacentor variabilis), Lone Star tick (Amblyomma americanum), and Brown dog tick (Rhipicephalus sanguineus) infestations in dogs and puppies 8 weeks of age and older, weighing 4 pounds of body weight or greater, for one month. NexGard® chews are also indicated for the prevention of Borrelia burgdorferi infections as a direct result of killing Ixodes scapularis vector ticks that transmit the bacterium that causes Lyme disease.
To learn more, visit NexGardforPets.com.
NexGard® Important Safety Information
NexGard® (afoxolaner) 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 full prescribing information, please click here.
NexGard® COMBO (esafoxolaner, eprinomectin, and praziquantel topical solution) Important Safety Information
- NexGard® COMBO is for topical use only in cats. The most frequently reported adverse reactions include vomiting, application site reactions, and anorexia. If ingested, hypersalivation may occur.
- For more information, click here for full prescribing information.
HEARTGARD® Plus Important Safety Information
HEARTGARD® Plus (ivermectin/pyrantel) is for dogs only. All dogs should be tested for heartworm infection before starting a preventive program. Following the use of HEARTGARD Plus, digestive and neurologic side effects have been reported. For more information, click here for full prescribing information.
Boehringer Ingelheim Animal Health
Boehringer Ingelheim Animal Health is working on first-in-class innovation for the prediction, prevention, and treatment of diseases in animals. For veterinarians, pet owners, farmers, and governments in more than 150 countries, we offer a large and innovative portfolio of products and services to improve the health and well-being of companion animals and livestock. As a global leader in the animal health industry and as part of family-owned Boehringer Ingelheim, we take a long-term perspective. The lives of animals and humans are interconnected in deep and complex ways. We know that when animals are healthy, humans are healthier too. By using the synergies between our Animal Health and Human Pharma businesses and by delivering value through innovation, we enhance the health and well-being of both.
For more information visit www.boehringer-ingelheim.com/animal-health.
Boehringer Ingelheim
Boehringer Ingelheim is working on breakthrough therapies that transform lives, today and for generations to come. As a leading research-driven biopharmaceutical company, the company creates value through innovation in areas of high unmet medical need. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term perspective. More than 52,000 employees serve over 130 markets in the three business areas, Human Pharma, Animal Health, and Biopharmaceutical Contract Manufacturing. Learn more at www.boehringer-ingelheim.com.
Intended audiences:
This press release is issued from our Corporate Headquarters in Ingelheim, Germany, and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business.
Media Contact:
Brett Israel
Boehringer Ingelheim Animal Health
Director of PR and Communications, U.S. Pets
brett.israel@boehringer-ingelheim.com
1 Data on file at Boehringer Ingelheim.
2 Data on file at Boehringer Ingelheim.
3 Data on file at Boehringer Ingelheim.
4 Hinkle, N. Yabsley, M. Asian Longhorned Tick in the Southeast. Practice Management. Feb. 2019:24-25.
NexGard® is a registered trademark and NexGard COMBO™ is a trademark of Boehringer Ingelheim Animal Health France, used under license. HEARTGARD® is a registered trademark of Boehringer Ingelheim Animal Health USA Inc. ©2023 Boehringer Ingelheim Animal Health USA Inc., Duluth, GA. All rights reserved. US-PET-0571-2023