Boehringer Ingelheim Receives FDA Approval for NexGard® PLUS (afoxolaner, moxidectin and pyrantel chewable tablets): A Beef-Flavored Soft Chew That Protects Dogs from Internal and External Parasites

Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) has approved the newest innovation from the trusted NexGard® Brand of Products — NexGard® PLUS (afoxolaner, moxidectin and pyrantel chewable tablets) — a monthly beef-flavored soft chew that protects dogs from fleas, ticks, heartworm disease, roundworms and hookworms. By combining internal and external parasite protection in a tasty, beef-flavored soft chew, NexGard® PLUS helps make monthly compliance easy and enjoyable for pets and pet owners.

“We’re committed to making it as easy as possible to care for pets, and NexGard® PLUS builds on our legacy in pet health to bring one-and-done monthly parasite protection to dogs in a beef-flavored soft chew,” said Daniel Watkins, Vice President of U.S. Pet at Boehringer Ingelheim Animal Health.  

With NexGard® PLUS, Boehringer Ingelheim adds to its robust parasiticide portfolio, giving veterinarians the flexibility to prescribe the right products for each pet and pet owner’s needs, including:

• #1 vet-recommended and #1 dog-preferred HEARTGARD® Plus (ivermectin/pyrantel)^{1, 2} 
• New NexGard® COMBO (esafoxolaner, eprinomectin, and praziquantel topical solution) for cats
• #1-dog preferred NexGard® (afoxolaner),³ which recently received FDA-approval for the treatment of Asian longhorned tick infestations 

Safe and effective against growing parasite threats

Internal and external parasite threats have expanded beyond their traditional regions and seasons.  Many tick species, for example, are now found in places that they didn’t exist a decade ago, and they are searching for a host whenever temperatures are above freezing. Fleas can be an ever-present risk for dogs throughout the U.S., and the heartworm disease prevalence has increased across much of the country. This is a contributing factor in the Companion Animal Parasite Council (CAPC) recommending that pet owners administer year-round broad-spectrum parasite control with efficacy against heartworm, intestinal parasites, fleas, and ticks.4

Multiple clinical studies showed that NexGard® PLUS is safe and effective against these growing threats^4,5:

• Treating and preventing flea infestations
• Killing adult fleas fast — ≥99.8% effective 24 hours after weekly infestations for a full month after treatment
• Treating and controlling common tick species — black-legged tick, lone star tick, American dog tick and brown dog tick — for one month
• Was 100% effective in preventing heartworm disease in dogs. For heartworm disease prevention, give once monthly for at least six months after last exposure to mosquitoes.
• Proven effective to treat and control roundworm and hookworm infections
• Safe for puppies as young as 8 weeks and weighing at least 4 pounds
• Safe for use in P-gp-deficient (MDR1-mutant) avermectin-sensitive dogs

Advancing Pet Healthcare Through Innovation

Each NexGard® PLUS chew has the same proven afoxolaner dose prescribed to millions of dogs in NexGard® (afoxolaner),⁶ and an optimized dose of moxidectin that is proven safe and effective.

To further enable compliance, veterinarians can prescribe 3-dose and 6-dose presentations to best support the needs of their canine patients.

“NexGard® PLUS is the one veterinarians will want to help keep dogs protected from parasites. It offers internal and external parasite protection in a single monthly chew that dogs will enjoy, is backed by our clinic support team, and is the latest innovation in our trusted parasiticide portfolio,” said Whit Cothern, DVM, Executive Director of Veterinary Professional Services at Boehringer Ingelheim Animal Health. “Veterinarians tackle complex challenges in their clinics every day, so we are proud to offer the solutions you want and the customer care that you want — all in one place.”

NexGard®PLUS will be available for veterinary clinics to order on July 31.

NexGard® PLUS Important Safety Information

NexGard® PLUS (afoxolaner, moxidectin, and pyrantel chewable tablets) are for use in dogs only. The most frequently reported adverse reactions reported in clinical trials were diarrhea, vomiting, lethargy, and itching. NexGard® PLUS contains afoxolaner, a member of the isoxazoline class, which has been associated with neurologic adverse reactions including tremors, ataxia, and seizures in dogs with or without a history of seizures. Use with caution in dogs with a history of seizures or neurologic disorders. The safe use of NexGard® PLUS has not been evaluated in breeding, pregnant, or lactating dogs. Dogs should be tested for existing heartworm infection prior to starting a heartworm disease preventive. For more information, click here for full prescribing information.

NexGard® COMBO Important Safety Information

NexGard® COMBO (esafoxolaner, eprinomectin, and praziquantel topical solution) is for topical use only in cats. Use with caution in cats with a history of seizures or neurologic disorders. For more information, click here for full prescribing information or visit NexGardCOMBOClinic.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 more information, click here for full prescribing information or visit NexGardClinic.com.

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. 

References

¹ Data on file at Boehringer Ingelheim.
² Data on file at Boehringer Ingelheim. 
³ Data on file at Boehringer Ingelheim. 
⁴ Guidelines for Dogs and Cats, Companion Animal Parasite Council. https://capcvet.org/guidelines/general-guidelines/ 
⁵ Freedom of Information Summary, NADA 141-554. NexGard® PLUS (afoxolaner, moxidectin, and pyrantel chewable tablets)
⁶ Data on file at Boehringer Ingelheim.