AVMA - American Veterinary Medical Association

12/17/2024 | News release | Distributed by Public on 12/17/2024 14:14

Drugs for treating atopic dermatitis in dogs, prevention of coccidiosis in poultry receive FDA approval

Animal drug manufacturers saw multiple approvals from the Food and Drug Administration (FDA) from August through November.

These include a new drug for atopic dermatitis in dogs, new supplemental approvals for antiparastic drugs for dogs and cats that protect against Asian longhorned ticks, and the first generic approval for a monensin Type A medicated article for certain chickens, turkeys, and quail.

Zenrelia

Elanco's Zenrelia received agency approval in September for the control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 1 year old. Zenrelia is available only by prescription from a licensed veterinarian.

Zenrelia (ilunocitinib tablets) is an immunosuppressant. Specifically, the drug is a nonselective Janus kinase (JAK) inhibitor that targets itch where it starts by blocking the pathways involved in allergic itch to break the itch-scratch cycle.

The dosage is 0.27 to 0.36 mg ilunocitinib per lb (0.6 to 0.8 mg ilunocitinib per kg) body weight, administered orally, once daily, with or without food. Zenrelia is supplied in scored tablets in four strengths: 4.8 mg, 6.4 mg, 8.5 mg, and 15 mg. Each tablet strength is available in 10 and 30 count blister packages and 90 count bottles.

Approximately 17 million dogs suffer from allergic skin disease, including atopic dermatitis, food allergies or flea sensitivity. Zenrelia offers visible improvement from the first dose and minimizes the risk of "rebound itch," according to Elanco. (Images courtesy of Elanco)

The company conducted a head-to-head study comparing the efficacy and safety of Zenrelia and Apoquel-another JAK inhibitor, this one from Zoetis. The randomized, double-blind study of 338 client-owned dogs with confirmed atopic dermatitis was conducted across 25 study sites in four countries. The study shows one daily dose of Zenrelia is at least as effective as Apoquel on Day 28.

Elanco also conducted a vaccine response study to evaluate how the drug affects the response to vaccination. In this study, eight, 10-month-old laboratory beagles received primary vaccinations while being treated with Zenrelia at three times the label dose. Two dogs became immunosuppressed after the study began and were euthanized during the study. Antibody responses were evaluated via serology tests following vaccination. All but one dog responded successfully to modified live vaccines. However, only two of six dogs responded to inactivated rabies vaccine at the primary endpoint.

The FDA says the results of the study demonstrate that it is not safe to administer vaccines in dogs that are concurrently receiving Zenrelia. "These animal and public health concerns can be mitigated by withholding Zenrelia for a certain amount of time before and after vaccination," the agency says.

"Zenrelia has been demonstrated to be safe and highly effective in a number of studies," said Dr. Mara Tugel, dermatology medical strategic lead at Elanco, in a company announcement. "We recognize that veterinarians need clinically relevant data to guide treatment choices, and plan to pursue additional studies to evaluate vaccine response in Zenrelia-treated dogs. We will continue to work to improve the label over time."

Credelio Quattro

Elanco's Credelio Quattro-lotilaner, moxidectin, praziquantel, and pyrantel chewable tablets-received approval in October. This combination antiparasitic drug with four active ingredients is given to dogs orally once a month, and available only by prescription.

Specifically, the drug is indicated for the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of roundworm (immature adult and adult Toxocara canis and adult Toxascaris leonina), hookworm (adult Uncinaria stenocephala), and tapeworm (Dipylidium caninum, Taenia pisiformis, and Echinococcus granulosus) infections.

It also kills adult fleas and is indicated for the treatment and prevention of flea infestations (Ctenocephalides felis) and the treatment and control of tick infestations-lone star tick, American dog tick, blacklegged tick, and brown dog tick-for one month in dogs and puppies 8 weeks of age and older and weighing 3.3 pounds or more.

Credelio Quattro is the newest addition to Elanco's Credelio franchise.

Credelio Quattro is available in five strengths of flavored chewable tablets formulated according to the weight of the dog. Each chewable tablet size is available in packages of one, six, or 12 tablets.

The minimum monthly dosage is 9 mg per lb (20 mg per kg) lotilaner, 0.009 mg per lb (0.02 mg per kg) moxidectin, 2.28 mg per lb (5 mg per kg) praziquantel, and 2.28 mg per lb (5 mg per kg) pyrantel (as pamoate salt).

Lotilaner belongs to the isoxazoline class and has been associated with neurologic adverse reactions such as tremors, ataxia, and seizures. The company advises using caution in dogs with a history of seizures or neurologic disorders. Also, dogs should be tested for existing heartworm infections before Credelio Quattro administration as it is not effective against adult D. immitis. The most frequently reported adverse reactions in clinical trials were vomiting and diarrhea.

Antiparasitic supplemental approvals

The FDA approved supplemental approvals for the following antiparasitic drugs:

  • Boehringer Ingelheim's NexGard Plus-afoxolaner, moxidectin, and pyrantel chewable tablets-now provides for the addition of the indication for the treatment and control of Asian longhorned tick, Haemaphysalis longicornis, infestations in dogs and puppies 8 weeks of age and older, weighing 4 pounds of body weight or greater, for one month. This supplemental approval also provides for the addition of label language regarding the results of a second flea field study and improvement of erythema, alopecia, papules, scales, crusts, and excoriation in dogs with flea infestations and signs of flea allergy dermatitis following treatment with afoxolaner alone, as a direct result of eliminating fleas.
  • Zoetis's Simparica Trio-sarolaner, moxidectin, and pyrantel chewable tablets-now provides for the addition of the indication for the treatment and control of Asian longhorned tick infestations for one month in dogs and puppies 8 weeks of age and older, and weighing 2.8 pounds or greater.
  • Zoetis's Simparica (sarolaner) now provides for the addition of the indication for the treatment and control of Asian longhorned tick infestations for one month in dogs 6 months of age or older and weighing 2.8 pounds or greater.
  • Intervet's Bravecto 1-month (fluralaner) now provides for the addition of the indication for the treatment and control of Asian longhorned tick infestations for one month in dogs and puppies 8 weeks of age and older, and weighing 4.4 pounds or greater.
  • Zoetis's Revolution Plus (selamectin and sarolaner topical solution) now provides for the addition of the indication for the prevention of tapeworm, Dipylidium caninum, infections as a direct result of killing Ctenocephalides felis vector fleas on the treated cat for one month in cats and kittens 8 weeks and older, and weighing 2.8 pounds or greater.
Simparica Trio is among antiparastic drugs for dogs and cats that received FDA supplemental approval for the addition of the indication for the treatment and control of Asian longhorned tick infestations.

Drugs in feed

Coxidin 90 became the first FDA-approved generic monensin Type A medicated article to be used in the manufacture of Type C medicated feeds for poultry.

It can be used for broiler and laying hen replacement chickens and layer breeder replacement chickens as an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima. For turkeys, Coxidin 90 is indicated for the prevention of coccidiosis in turkeys caused by E. adenoeides, E. meleagrimitis, and E. gallopavonis. And for quail, the drug is approved for the prevention of coccidiosis in growing Bobwhite quail caused by E. dispersa and E. lettyae.

The FDA has approved the first generic monensin Type A medicated article for certain chickens, turkeys, and quail.

The drug's sponsor, Huvepharma EOOD, demonstrated that Coxidin 90 is bioequivalent to the approved brand-name drug product, Coban 90.

Coxidin 90 is an ionophore and anticoccidial that contains 90.7 g per lb of the active ingredient monensin, which is a locally active, poorly soluble drug.

Coxidin 90 is supplied in 25 kg (55.12 lb) bags and is available over the counter.
The dosages are as follows:

  • Broiler chickens, laying-hen replacement chickens, and layer-breeder replacement chickens: 90 to 110 g per ton
  • Growing turkeys: 54 to 90 g per ton
  • Growing Bobwhite quail: 73 g per ton

Coxidin 90 should be fed to poultry completely and continuously as the sole ration.

Paqflor (florfenicol) from Phibro Animal Health received label approval for its generic version of Aquaflor, originally put out by Intervet, one of only a few drugs approved for use in fish. It is a Type A medicated article to be used in the manufacture of Type C medicated feeds.

Paqflor is indicated for the control of mortality due to furunculosis associated with Aeromonas salmonicida and coldwater disease associated with Flavobacterium psychrophilum in freshwater-reared salmonids.

In freshwater-reared finfish, it is indicated for the control of mortality due to columnaris disease associated with Flavobacterium columnare. And in catfish, for the control of mortality due to enteric septicemia of catfish associated with Edwardsiella ictaluri.

This antimicrobial, available through a veterinary feed directive, contains 500 g per kg (227.27 g per lb) of florfenicol and is supplied 2 kg packets. The dosage is 10-15 mg per kg body weight for 10 consecutive days for freshwater-reared salmonids, freshwater-reared finfish, and catfish. For freshwater-reared warmwater finfish, Paqflor is dosed in 15 mg per kg body weight for 10 consecutive days.

In addition, the FDA approved a handful of new animal drugs containing the active ingredient melengesterol acetate. They are as follows:

  • MGA and Deracin (melengestrol acetate Type A medicated article and chlortetracycline Type A medicated article)
  • MGA and Bovatec and Deracin (melengestrol acetate Type A medicated article) and (lasalocid Type A medicated article) and (chlortetracycline Type A medicated article)
  • MGA and Experior (melengestrol acetate Type A medicated article and lubabegron Type A medicated article)
  • MGA and Experior and Rumensin and Tylan (melengestrol acetate Type A medicated article and lubabegron Type A medicated article and monensin Type A medicated article and tylosin phosphate Type A medicated article)
  • MGA and Experior and Rumensin (melengestrol acetate Type A medicated article and lubabegron Type A medicated article and monensin Type A medicated article)
  • MEL 500 (melengestrol acetate Type A liquid medicated article)

Dosage-form drugs

Two versions of a generic tulathromycin injection solution-Tulaject 25 and Tulaject 100-were approved for use in swine; beef and nonlactating dairy cattle; and suckling calves, dairy calves, and veal calves.

Specifically, Tulaject 25 is indicated for the treatment of calves with bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis; and for the control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis.

It is also indicated for the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica, Haemophilus parasuis, and Mycoplasma hyopneumoniae; and for the control of SRD associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma hyopneumoniae in groups of pigs where SRD has been diagnosed.

Tulaject 25 and Tulaject 100 are indicated for the treatment of calves with bovine respiratory disease, among other conditions.

Further, Tulaject 100 is indicated for the treatment of the previously mentioned conditions as well as BRD associated with M. haemolytica, P. multocida, H. somni, and M. bovis; infectious bovine keratoconjunctivitis associated with Moraxella bovis; and bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii in beef and nonlactating dairy cattle.

Tulaject 25 and Tulaject 100 are antimicrobials that contain the same active ingredient, tulathromycin, and are bioequivalent to the approved brand-name drug product, Draxxin.

Tulaject 25 is supplied in 50 mL, 100 mL, and 250 mL vials containing a tulathromycin concentration of 25 mg per mL. Tulaject 100 is supplied in 50 mL, 100 mL, 250 mL, and 500 mL vials containing a tulathromycin concentration of 100 mg per mL. Both are available by prescription from a licensed veterinarian.

In swine, Tulaject 25 is administered as an intramuscular injection in the neck at a dose of 2.5 mg per kg (1 mL per 22 lb) body weight.

In calves, Tulaject 25 is administered as an intramuscular injection in the neck, also at a dose of 2.5 mg per kg (1 mL per 22 lb).

In swine, Tulaject 100 is administered as an intramuscular injection in the neck at a dose of 2.5 mg per kg (0.25 mL per 22 lb).

In cattle, Tulaject 100 is administered as an intramuscular injection in the neck at a dose of 2.5 mg per kg (1.1 mL per 100 lb).

Tulaject 25 and Tulaject 100 are sponsored by Cronus Pharma Specialities India Private based in Hyderabad, India.

Finally, the FDA approved PropofolVet Multidose, the first generic propofol injectable emulsion for dogs. PropofolVet Multidose is approved for use as an injectable anesthetic in dogs.

PropofolVet Multidose contains the same active ingredient, propofol injectable emulsion, as the approved brand name drug product, PropoFlo 28, which was first approved in February 2011. In addition, the FDA determined that PropofolVet Multidose contains no inactive ingredients that may significantly affect the bioavailability of the active ingredient.

PropofolVet Multidose is supplied in a 10 mg per mL concentration in 20mL multidose vials.

PropofolVet Multidose is sponsored by Parnell Technologies Pty. Ltd. based in New South Wales, Australia.