Elanco Receives USDA Approval for Befrena™ (tirnovetmab), a New Anti-IL31 Monoclonal Antibody Injection Targeting Canine Allergic and Atopic Dermatitis | ELAN Stock News

Elanco's second dermatology product approval in less than 18 months in the estimated $1.3 billion U.S. canine dermatology marketBefrena has been shown to be effective for treatment of dogs of any age against canine atopic dermatitis and allergic dermatitis for 6 to 8 weeks of treatment, as neededUSDA approval of Befrena reinforces Elanco's commitment to going beyond to deliver differentiated, high-quality products in every key therapeutic area, bolstering its leadership in canine dermatology and monoclonal antibodies (mAbs)Canine allergic and atopic dermatitis is a widespread concern amongst veterinarians, with data revealing that nearly 98% of vets say they routinely treat dogs for atopic dermatitis and that itchy dogs make up nearly 20% of their patient populationi, /PRNewswire/ -- Elanco Animal Health Incorporated (NYSE: ELAN) today announced its latest entry into the rapidly growing canine dermatology space with the U.S. Department of Agriculture (USDA) approval of Befrena™ (tirnovetmab), a new anti-IL31 monoclonal antibody (mAb) injection targeting canine allergic and atopic dermatitis. Importantly, Befrena is recommended at a dosing interval of 6 to 8 weeks post-treatment, which stands in contrast to the 4 to 8 weeks of the current market competitor, lokivetmab.USDA approval of Befrena further demonstrates Elanco's commitment to going beyond to deliver differentiated, high-quality products in every key therapeutic area, specifically bolstering its leadership in canine dermatology and monoclonal antibodies. Elanco continues to expect to launch Befrena in the first half of 2026.The approval of Befrena marks Elanco's second dermatology product approved in less than 18 months, as it joins Zenrelia™ (ilunocitinib tablets), 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. In September, Elanco announced improvements to the U.S. Zenrelia label with the Food and Drug Administration (FDA) concluding "the totality of evidence supports removal of the risk of fatal vaccine-induced disease from modified live virus vaccines from the labelingii."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."The animal health sector is increasingly focused on antibody-based therapies, and today's approval is an important step forward in delivering high-impact innovation that enhances the quality of life for pets," said Dr. Ellen de Brabander, Executive Vice President of Research & Development at Elanco. "We are pleased to offer veterinarians and pet owners Befrena, which delivers long lasting relief to treat dogs with allergic itch." Earlier this year Elanco launched the America's Itchy Dogs Report, a first-of-its-kind report highlighting the impact itch has on dogs, their owners, and veterinarians. The report includes findings from multiple surveys of pet owners, as well as veterinarians, and reveals startling details on how badly dogs around the country are itching for relief and cost-effective, long-lasting solutions. According to the report, 9 in 10 dogs in the U.S. are "itchy dogs" according to their pet owners, having experienced symptoms of itchiness at some point in the year.iii Pet owners typically try many at-home solutions before finally seeking veterinary care. On average, pet owners spend about $400 on over-the-counter remedies and wait six weeks before taking their pet to the veterinarian. Veterinarians say that itchy dog owners wait too long before bringing their dog, resulting in raw and infected skin and also an irritated dog owner who wants their dog to experience relief quickly.iv Research shows that nearly 70% of veterinarians would be willing to stock another dermatology product in an effort to help more dogs find itch relief.v"Veterinarians need more options for itch relief so they can offer targeted therapy that focuses on mode of action to meet the unique needs of the individual patient to deliver fast, effective and valuable itch relief," said Dr. Griffin, veterinary dermatologist. "USDA approval of Befrena brings veterinarians a step closer to having another beneficial and safe treatment option. I'm excited to collaborate with Elanco and plan to offer this product in my practice when it becomes available."You can learn more about Befrena and sign up for future news and webinars at www.befrenaforvets.com.ABOUT ELANCOElanco Animal Health Incorporated (NYSE: ELAN) 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. With 70 years of animal health heritage, we are committed to breaking boundaries and going beyond to help our customers improve the health of animals in their care, while also making a meaningful impact on our local and global communities. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose – all to Go Beyond for Animals, Customers, Society and Our People. Learn more at www.elanco.com.INDICATIONSZenrelia is a prescription medication used to control itching and inflammation associated with skin allergies for dogs over 12 months of age.IMPORTANT SAFETY INFORMATIONRead the package insert, including the Boxed Warning, before using this drug. For full prescribing information speak with your veterinarian, call 1 888 545 5973 or visit www.elancolabels.com/us/zenrelia.WARNING: INADEQUATE IMMUNE RESPONSE TO VACCINES. Based on results of the vaccine response study, dogs receiving Zenrelia are at risk of an inadequate immune response to vaccines. Discontinue Zenrelia for at least 28 days to 3 months prior to vaccination and withhold Zenrelia for at least 28 days after vaccination. Dogs should be up to date on vaccinations prior to starting Zenrelia. Do not use in dogs less than 12 months old or dogs with a serious infection. Dogs should be monitored for infections because Zenrelia may increase the chances of developing an infection. Neoplastic conditions (benign and malignant) were observed during clinical studies. The most common side effects were vomiting, diarrhea and tiredness. Zenrelia has not been tested in dogs used for breeding, pregnant, or lactating dogs and has not been evaluated in combination with glucocorticoids, cyclosporine, or other immune suppressive drugs.Befrena, Zenrelia, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates. © 2025 Elanco or its affiliatesi Elanco Animal Health. Data on File.ii Zenrelia Supplemental FOI Summaryiii Elanco Animal Health. Data on File.iv Elanco Animal Health. Data on File.v AVMA Pet Ownership and Demographic Sourcebook 2022 and Elanco Animal Health. Data on File.Investor Contact: Tiffany Kanaga (765) 740-0314 tiffany.kanaga@elancoah.comMedia Contact: Season Solorio (765) 316-0233 season.solorio@elancoah.com SOURCE Elanco Animal Health