The U.S. Food and Drug Administration last week approved Zenrelia, or ilunocitinib tablets, a new veterinary drug from Elanco Animal Health, Inc., based in Greenfield, Indiana, to control pruritus, or itching, associated with allergic dermatitis and to control atopic dermatitis, or environmental allergies, in dogs that are at least a year old.
According to Elanco Animal Health, itching is one of the top reasons pet owners take their dogs to the veterinarian, and pet owners and veterinarians want more canine dermatology options. Approximately 17 million dogs in the USA suffer from allergic skin disease, including atopic dermatitis, food allergies, or flea sensitivity, the company said in a press release. Among pet owners who say their dog’s itch is not under control, 60% say they have tried treating the itch, but nothing works, the company added.
Zenrelia is an immunosuppressant that is to be administered orally, once daily, with or without food, the FDA said in its release. The active ingredient, ilunocitinib, is a non-selective Janus kinase inhibitor and is the second Janus kinase inhibitor the drug regulator has approved for this indication.
“Today is a historic day for Elanco with our first of several expected entries into the fast-growing global canine dermatology market, bringing veterinarians and pet owners a highly effective new solution that got more dogs back to normal levels of itch in a head-to-head study with the current JAK (Janus kinase) inhibitor on the market,” said Jeff Simmons, president and chief executive officer, Elanco Animal Health.
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Simmons said Elanco was “excited to offer veterinarians and pet owners a solution that can relieve the burdens of itch, while also becoming just the second animal health company to offer veterinarians a comprehensive portfolio, including parasiticides, vaccines, pain and other therapeutics, and now, dermatology”.
While the FDA said Zenrelia is safe and effective when used according to the label, it drew attention to a boxed warning on the label that says dogs should not be vaccinated at least 28 days before and after treatment with the drug, due to the risk of fatal vaccine-induced disease and inadequate immune response to vaccines.
In a vaccine response study where dogs received both vaccinations and Zenrelia, treated dogs experienced drug-induced suppression of the immune system, which resulted in fatal vaccine-induced adenoviral hepatitis (inflammation of the liver) and pancreatitis (inflammation of the pancreas) in one dog and infectious enteritis (inflammation of the intestines) in another, the FDA cautioned.
Additionally, because Zenrelia works in part by suppressing the immune system, treated dogs that receive vaccines at the same time may not mount an adequate immune response to the vaccine. In the study, four of six treated dogs failed to mount an adequate immune response to the rabies vaccine and one dog failed to mount an adequate response to the canine distemper vaccine. This is especially problematic for the rabies vaccine, because rabies is an almost always fatal zoonotic disease.
The FDA said in the release that these animal and public health concerns can be addressed by withholding Zenrelia for at least 28 days to three months before vaccination and for at least 28 days afterwards, and by making sure a dog is up-to-date on vaccinations before starting treatment.
Zenrelia is only available by prescription from a licensed veterinarian because veterinary expertise is needed to determine whether Zenrelia is an appropriate treatment for a pet and to monitor the patient for the possible development of infections or other potential side effects while on the drug.
The drug is available 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.
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