Elanco Animal Health announced on June 27, 2024, that the U.S. label for Zenrelia, its once-daily oral inhibitor for canine dermatology, is expected to include a boxed warning on safety. This warning is based on a trial with unvaccinated dogs dosed at three times the label dose, which Elanco believes will slow the product adoption curve in the U.S. and initially limit treatment days by approximately 25%.
The company also updated its expected U.S. Food and Drug Administration (FDA) approval timelines for both Zenrelia and Credelio Quattro. Zenrelia's FDA approval is now anticipated in the third quarter of 2024, with a potential commercial launch in the fourth quarter of 2024, a delay from previous expectations.
Furthermore, Credelio Quattro, a broad-spectrum parasiticide product for dogs, is now expected to receive FDA approval in the fourth quarter of 2024. These delays and the safety warning for Zenrelia represent significant setbacks for Elanco's innovation pipeline and its projected revenue growth from these key products.
The content on BeyondSPX is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.