ELAN - Elanco Animal Health Shares Sink On Unexpected Label Update For Canine Dermatology Drug | Benzinga
Elanco Animal Health Incorporated (NYSE:ELAN) stock is tumbling as the company released updates to the expected FDA approval timelines for Zenrelia and Credelio Quattro.
Zenrelia is a JAK Inhibitor that controls pruritus and atopic dermatitis in dogs.
For Zenrelia, the FDA confirmed that all major technical sections (Effectiveness, Safety and Chemistry, Manufacturing, and Controls (CMC)) are complete as of late June.
For the minor technical section for labeling, earlier this week, the company aligned with the FDA on the language and expects to receive the completion letter by mid-July.
The 60-day final administrative review will follow, placing expected approval late in the third quarter of 2024. The company anticipates a U.S. launch for Zenrelia in the fourth quarter of 2024.
Investors are reacting to the box-label warning on Zenrelia, which was possibly unexpected.
“However, we expect the U.S. label will include a boxed warning on safety based on the outcome of a trial with unvaccinated dogs dosed at 3x the label dose,” said Bobby Modi, Elanco Executive Vice President U.S. Pet Health and ...