Befrena offers 6-8 weeks of itch relief for dogs suffering from allergic and atopic dermatitis, though South African availability remains uncertain

Elanco Animal Health has received USDA approval for a new treatment that could bring extended relief to the millions of dogs suffering from allergic itching. Tirnovetmab (marketed as Befrena) was approved on 31 December 2025 and represents the second dermatology product Elanco has brought to market in less than 18 months.

Whilst the approval is currently limited to the United States, the development represents an important advancement in canine dermatology that may eventually benefit dogs globally. South African dog owners should be aware, however, that the product is unlikely to be available locally for some time, as it will require separate regulatory approval from the South African Health Products Regulatory Authority (SAHPRA) before it can be marketed in the country.

The anti-IL31 monoclonal antibody injection targets canine allergic and atopic dermatitis – conditions that affect an estimated 79 million dogs in the United States alone. According to Elanco’s America’s Itchy Dogs Report, nine out of 10 dogs have experienced symptoms of itchiness at some point during the year.

How Befrena works

Befrena works by targeting interleukin-31 (IL-31), a protein that plays a key role in triggering the itch sensation in allergic dogs. By neutralising IL-31, the treatment helps break the itch-scratch cycle that can lead to raw, infected skin and misery for both dogs and their owners.

The treatment is administered as an injection and provides relief for 6-8 weeks post-treatment. This represents a slight extension over its main competitor currently on the market, which recommends dosing intervals of 4-8 weeks.

“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 and development at Elanco. “We are pleased to offer veterinarians and pet owners Befrena, which delivers long-lasting relief to treat dogs with allergic itch.”

The scale of the problem

Elanco’s America’s Itchy Dogs Report, released in 2025, revealed the significant impact that allergic skin disease has on dogs, their owners, and veterinary practices. The research found that pet owners spend an average of £400 (at least R8000) on over-the-counter remedies before seeking veterinary care, typically waiting six weeks whilst trying to solve the problem at home.

This delay often results in dogs presenting with raw, infected skin and frustrated owners desperate for relief for their pets. The economic and emotional toll is substantial, affecting both animal welfare and the human-animal bond.

Filling a treatment gap

The approval of Befrena addresses what many veterinarians see as a critical need for additional treatment options. According to Elanco research, nearly 70% of veterinarians would be willing to stock another dermatology product in their clinics to help more patients find itch relief.

“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 Joya Griffin, a 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.”

Building a dermatology portfolio

Befrena joins Zenrelia in Elanco’s dermatology portfolio, demonstrating the company’s commitment to addressing skin conditions in companion animals. The approval represents Elanco’s second dermatology product to receive regulatory clearance in less than 18 months, a rapid expansion of treatment options for a condition that affects the vast majority of canine patients at some point in their lives.

The new product is scheduled to launch in the first half of 2026, giving veterinarians and dog owners another tool in the management of allergic and atopic dermatitis.

What this means for dog owners

For owners of dogs suffering from allergic skin disease, the approval of Befrena represents welcome news, though it’s important to note that this is currently a US development. South African dog owners will need to wait for local regulatory approval before the treatment becomes available through their veterinarians.

The regulatory pathway for veterinary medicines in South Africa typically involves review by SAHPRA, and there is no confirmed timeline for when or if Befrena will be submitted for approval in the South African market. Elanco has not yet announced plans for international rollout beyond the United States.

In the meantime, South African veterinarians continue to have access to existing treatments for allergic dermatitis, including other monoclonal antibody therapies that have already received local approval. Dog owners concerned about their pets’ itching should consult their veterinarian about currently available options.

The science of allergic dermatitis

Allergic and atopic dermatitis in dogs can have multiple triggers, including environmental allergens (such as pollen, dust mites, and moulds), food sensitivities, and flea bites. The conditions are often chronic and require long-term management rather than a one-time cure.

Traditional treatments have included antihistamines, corticosteroids, and immunotherapy, each with varying degrees of effectiveness and potential side effects. The development of targeted biological therapies like Befrena represents a shift towards more specific treatment approaches that aim to interrupt the allergic response at a molecular level.

Befrena (tirnovetmab), an anti-IL31 monoclonal antibody, was approved by the USDA on 31 December 2025 for the treatment of canine allergic and atopic dermatitis in the United States. The product is expected to launch in the US in the first half of 2026. South African regulatory approval and availability have not been announced.