|
Elanco Animal Health Incorporated, a global leader in animal health, announced important updates to the US Zenrelia label, following the Food and Drug Administration (FDA) review of supplemental scientific data.
Approved by the FDA in September 2024, Zenrelia is an effective, convenient, and safe once-daily oral JAK inhibitor for control of itching and inflammation associated with skin allergies in dogs at least 12 months of age. Over half a million dogs around the world have been treated with Zenrelia. Elanco is inspired by the positive and growing feedback from dermatologists, general practice veterinarians and pet owners.
At launch, the US Zenrelia label included language based on the outcome of a laboratory study of unvaccinated dogs dosed at three times the label dose of Zenrelia. During that study, an outbreak of concurrent diseases occurred, complicating interpretation of the results.
Upon evaluation of additionally submitted data, the FDA now concludes that “the totality of evidence supports removal of the risk of fatal vaccine-induced disease from modified live virus vaccines from the labelling,” and this language has subsequently been removed from the Zenrelia label in the US. The label Boxed Warning continues to advise discontinuation of Zenrelia for at least 28 days to 3 months prior to vaccination and withholding Zenrelia for at least 28 days after vaccination due to the risk of inadequate immune response to vaccines.
“We appreciate the FDA’s commitment to reviewing the latest submitted scientific data to ensure that the label is reflective of the totality of evidence,” said Dr. Ellen DeBrabander, executive vice president, research & development at Elanco. “This now brings the US label a step closer to the approved Zenrelia label in markets such as the European Union, Great Britain, Brazil and Japan. We are committed to generating additional data in our efforts to further strengthen the US label.”
The totality of the evidence around Zenrelia continues to support the safety and efficacy of the product when used according to label directions. Prior to using this drug, it is important to read the entire label, including the Boxed Warning related to concurrent vaccine administration. Veterinarians can review additional peer reviewed and published studies on Zenrelia.
• Response to primary canine core vaccination in 10-month-old seronegative dogs treated with three times the recommended therapeutic dose of ilunocitinib tablets (Zenrelia), published in BMC Veterinary Research
• Efficacy and field safety of ilunocitinib for the control of allergic dermatitis in client-owned dogs: a multicenter, double-masked, randomised, placebo-controlled clinical trial, published in Veterinary Dermatology
• Efficacy and field safety of ilunocitinib for the control of atopic dermatitis in client-owned dogs: A multicentre, double-masked, randomised, placebo-controlled clinical trial, published in Veterinary Dermatology
• Comparative efficacy and safety of ilunocitinib and oclacitinib for the control of pruritus and associated skin lesions in dogs with atopic dermatitis, published in Veterinary Dermatology
Zenrelia has achieved remarkable performance across the globe in its first year, with product now available in the European Union, Great Britain, Brazil, Canada, Japan, and the United States. Dogs like Trooper, Scrappy, Remi, Missy, Hunter and River have seen real-world outcomes from Zenrelia.
“Zenrelia has gained momentum, with more veterinarians buying and prescribing Zenrelia to more dogs each month,” said Bobby Modi, executive vice president, US Pet Health and Global Digital Transformation at Elanco. “More than 90% of US veterinarians are aware of Zenrelia and 80% of US clinics re-ordered Zenrelia after they experience results first-hand.”
Earlier this year, Elanco released the America’s Itchy Dogs Report. The first-of-its-kind report includes results from multiple surveys revealing just how badly dogs around the country are itching for relief. Nearly 8 in 10 itchy dog owners who have switched veterinarians report they switched after 3 visits or less. This puts more pressure on dermatologists and veterinarians to help dogs find itch relief quickly.
“I’ve been using Zenrelia in my practice for several months,” said Dr. Tannetje Crocker, owner of Alta Vista Animal Hospital in Fort Worth, TX. “With fall allergies in full-swing, I’m using Zenrelia as a first-line treatment option, both in new, as well as seasonal cases. This updated label makes it easier for me to have conversations with pet owners about Zenrelia.”
When initiating treatment with Zenrelia, refer to label directions. Zenrelia should only be used in dogs that are up to date on vaccinations, at least 12 months old and free from serious infection.
“As a dermatologist, I tend to see patients that need quick improvement—the owner is likely frustrated, the dog is itchy and inflamed, and I know that I need to help them find relief,” Dr. Andrew Rosenberg, veterinarian and President of the American College of Veterinary Dermatology (AVCD).?“Zenrelia has become an integral component of my first-line therapeutic approach.”
Zenrelia is a prescription medication used to control itching and inflammation associated with skin allergies for dogs over 12 months of age.
Elanco Animal Health Incorporated is a global leader in animal health dedicated to innovating and delivering products and services to prevent and treat disease in farm animals and pets, creating value for farmers, pet owners, veterinarians, stakeholders and society as a whole.
|