Elanco Secures USDA Approval For Befrena, Expands Dermatology Portfolio

Elanco Animal Health

20.28 EUR -1.05%

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(RTTNews) - Elanco Animal Health Inc. (ELAN) announced that the U.S. Department of Agriculture (USDA) has approved Befrena (tirnovetmab), a new anti-IL31 monoclonal antibody injection designed to treat canine allergic and atopic dermatitis. Befrena is recommended at a dosing interval of 6 to 8 weeks, offering a longer treatment window compared to the current market competitor, lokivetmab, which is administered every 4 to 8 weeks.

The company expects to launch Befrena in the first half of 2026, further strengthening its position in the veterinary dermatology market.

This approval marks Elanco's second dermatology product clearance in less than 18 months. Befrena joins Zenrelia (ilunocitinib tablets), a once-daily oral JAK inhibitor that provides effective, convenient, and safe control of itching and inflammation associated with skin allergies in dogs aged 12 months and older.

In September, Elanco announced enhancements to the U.S. Zenrelia label. The Food and Drug Administration (FDA) concluded that "the totality of evidence supports removal of the risk of fatal vaccine-induced disease from modified live virus vaccines" from the product's labeling.

Despite this update, the Boxed Warning remains in place, advising veterinarians to discontinue Zenrelia for at least 28 days to 3 months prior to vaccination and to withhold treatment for at least 28 days after vaccination.

ELAN closed trading on December 31 at $22.63, down $0.13 or 0.57% from the previous session. In after-hours trading, the stock slipped further to $22.16, a decline of $0.47 or 2.08%.

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