Elanco Animal Health received USDA approval for Befrena (tirnovetmab), a monoclonal antibody that targets interleukin‑31 to treat canine allergic and atopic dermatitis, on December 31, 2025. The approval extends the company’s dermatology lineup and positions it to capture a larger share of the U.S. canine dermatology market, estimated at $1.3 billion.
Befrena offers a dosing interval of 6 to 8 weeks, longer than the current market competitor lokivetmab, which requires 4 to 8 weeks. The extended interval is expected to improve owner compliance and reduce veterinary visit frequency, giving Elanco a competitive edge.
The drug is slated for launch in the first half of 2026, adding a high‑margin revenue stream to Elanco’s pet‑health portfolio. Befrena follows Zenrelia, another Elanco dermatology product approved less than 18 months earlier, underscoring the company’s rapid expansion in this therapeutic area.
Elanco’s recent financial performance highlights the strategic importance of Befrena. In Q4 2024, the company reported revenue of $1.020 billion, a 1 % decline on a reported basis but a 4 % increase on an organic constant‑currency basis compared to Q4 2023. Adjusted EBITDA rose 7 % to $177 million, reflecting disciplined cost management amid a mixed‑segment mix.
Within the pet‑health segment, revenue grew 6 % in Q4 2024, driven by strong demand for core products and the momentum from new launches. The farm‑animal segment, however, fell 7 % as commodity prices and input costs pressured margins. Management emphasized that the innovation pipeline, including Befrena, is a key driver of future growth and margin expansion.
CEO Jeff Simmons noted that Elanco “delivered a strong finish to 2024, achieving six consecutive quarters of organic constant‑currency revenue growth and building momentum as we head into 2025.” He added that the company has exceeded its 2024 innovation revenue target and raised the goal for 2025, with six potential blockbuster products now launched.
The approval of Befrena strengthens Elanco’s leadership in canine dermatology and supports its broader strategy to grow its innovation pipeline across both pet and farm animal segments. The extended dosing interval and high‑margin profile position Befrena to capture a meaningful share of the growing market, potentially translating into significant revenue and earnings growth as the product gains market penetration.
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