Credelio Quattro advances to final FDA administrative review

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Elanco Animal Health Incorporated (Elanco) announced that Credelio Quattrohas completed its review of all major and minor technical sections with the FDA. The product has now moved into the final 60-day administrative review that is currently underway.

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

According to the release,¹ Elanco is continuing to expect Credelio Quattro is to seek approval for indications that would give the product the broadest coverage, including fleas, ticks, heartworms as well as internal parasites like tapeworms.¹ Elanco also disclosed that along with the regulatory process, it has plans to finalize a manufacturing scale-up to help optimize the launch, andis targeted for the first quarter in 2025.

Earlier in the process, Credelio Quattro completed 2 out of the 3 major technical sections, Effectiveness and Safety. However, in June 2024, the company received an incomplete letter for the chemistry, manufacturing, and controls major technical section.² At that time, the company went forward with the minor technical sections as this was happening, including Labeling.

“We are very pleased with the continued progress of our pipeline. We completed the Bovaer review ahead of schedule and now have two potential blockbusters – Zenrelia and Credelio Quattro – in the final administrative review at the FDA, illustrating our R&D organization’s high capacity and ability to build capabilities to deliver a consistent flow of high-impact innovation,” said Ellen de Brabander, PhD, executive vice president of innovation and regulatory affairs.¹

“A significant thank you to the Elanco team for their efforts to bring these differentiated innovations toward approval while also refilling and advancing the early-stage pipeline for the next era of innovation.”

Along with Credelio Quattro, Elanco has an additional product, Zenrelia, that has received confirmation from the FDA that it has completed all major technical sections as of late June 2024. For the minor technical sections, the company aligned with FDA language and is currently waiting to receive the completion. Elanco is anticipating the launch of Zenrelia in the United States in the fourth quarter of 2024.²

References

1. Elanco Announces Credelio Quattro Moves to Final FDA Administrative Review. News 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. News release. June 27, 2024. Accessed August 20, 2024. https://www.prnewswire.com/news-releases/elanco-provides-innovation-update-302183924.html