Credelio Quattro Passes FDA Final Administrative Review

Elanco Animal Health Incorporated (Elanco) announced that Credelio Quattrohas has completed review of all major and minor technical sections with the FDA. The product has now entered a final 60-day administrative review, which is currently ongoing.

“This is an exciting time for Elanco as we deliver a robust portfolio of innovations that we believe will help transform pet care with solutions that go beyond today’s market leaders,” said Jeff Simmons, president and CEO of Elanco, in an organizational release.¹ “Elanco expects to launch a potential blockbuster in each of the next three quarters in large, fast-growing or new markets that are largely favorable to Elanco. We continue to expect $600 million to $700 million in innovation sales in 2025.”

According to the announcement,¹ Elanco continues to expect that Credelio Quattro will seek approval for indications that will provide the product with the broadest spectrum of protection, including fleas, ticks, heartworms, as well as internal parasites such as tapeworms.¹ Elanco also revealed that in addition to the regulatory process, it plans to finalize production scale-up to optimize launch, which is targeted for the first quarter of 2025.

Earlier in the process, Credelio Quattro completed 2 of the 3 main technical sections, Efficiency and Safety. However, in June 2024, the company received an incomplete letter regarding the main technical section on Chemistry, Production and Control.² During this time, the company addressed minor technical issues, including labeling.

“We are very pleased with the continued progress in our pipeline. We completed our Bovaer review ahead of schedule and now have two potential blockbuster candidates – Zenrelia and Credelio Quattro – in final administrative review with the FDA, illustrating the strong capabilities of our R&D organization and our ability to build capacity to deliver a steady stream of high-impact innovations,” said Ellen de Brabander, Ph.D., executive vice president, Innovation and Regulatory Affairs.¹

“A heartfelt thanks to the Elanco team for their efforts in bringing these diverse innovations to validation, and in completing and evolving the early phase process for the next era of innovation.”

In addition to Credelio Quattro, Elanco has an additional product, Zenrelia, that has received FDA confirmation that it has completed all major technical sections by the end of June 2024. For minor technical sections, the company has complied with FDA language and is currently waiting to receive completion. Elanco expects to launch Zenrelia in the United States in the fourth quarter of 2024.²

References

1. Elanco Announces Credelio Quattro Moves to Final FDA Administrative Review. Press release. Elanco Animal Health Incorporated. August 20, 2024. Accessed August 20, 2024. https://www.elanco.com/en-us/insights/credelio-quattro-moves-to-final-fda-administrative-review
2. Elanco Provides Innovation Update. Press release. June 27, 2024. Accessed August 20, 2024. https://www.prnewswire.com/news-releases/elanco-provides-innovation-update-302183924.html