TriviumVet Secures FDA Conditional Approval for First Treatment for Feline Cardiac Disease
TriviumVet’s felycin®-CA1 has been granted conditional approval by the U.S. Food and Drug Administration (FDA). This marks a significant milestone in feline cardiac care as the first approval for a feline cardiology drug and the first product approved for use in cats with HCM for any indication. felycin®-CA1 (sirolimus delayed release tablets), administered once weekly, is indicated for the management of ventricular hypertrophy in cats with subclinical hypertrophic cardiomyopathy (HCM).
HCM is the “most common heart disease in cats and is one of the most common causes of death in cats”1, and until now, there have been no FDA-approved treatments available. This approval offers veterinarians and pet owners a much-needed option for managing subclinical HCM, providing new hope for affected cats. TriviumVet, an Ireland-based veterinary company, has spent the past five years collaborating with trusted U.S. research partners to bring this innovative treatment to market.
Feline HCM is extremely common, affecting 1 in 7 of all pet cats. In animals 9 years of age and older, the prevalence rises to approximately 1 in 32 and is a leading cause of mortality in adult cats. The disease is characterized by abnormal thickening and impaired function of the ventricular wall of the heart. While some cats remain asymptomatic, around half go on to develop congestive heart failure or other severe complications. Subclinical HCM refers to cases that have ventricular wall thickening but have not yet developed clinical signs.
felycin®-CA1’s species-specific delayed-release formulation targets the subclinical phase of the disease, prior to the onset of heart failure, and has been shown to reduce thickening (hypertrophy) of the ventricular wall3. Administered orally once weekly, felycin®-CA1 is set to fundamentally change the feline HCM treatment landscape. The HCM treatment market is underserved, and there is increasing willingness of pet owners to invest in advanced treatments options. ‘felycin-CA1 is the first and only medication shown to reduce the ventricular hypertrophy that is the principal feature of subclinical HCM. It provides a valuable treatment option for veterinarians and pet owners and will transform the way feline HCM is managed’ said Stuart Fitzgerald, Chief Scientific Officer at TriviumVet.
Commitment to Ongoing Research
An animal drug is eligible for conditional approval if it addresses a serious or life-threatening disease, or addresses an unmet animal or human health need, felycin®-CA1 met this requirement as subclinical HCM often progresses to clinical HCM, which substantially impacts day-to-day functioning in cats and can be fatal. TriviumVet is conducting the HALT HCM Study, a pivotal clinical trial involving over 20 investigator sites across the United States. This study aims to further demonstrate the efficacy of felycin®-CA1 in managing ventricular hypertrophy in cats with subclinical HCM. The HALT HCM Study is progressing significantly ahead of expectations, with enrolment currently nearing 50% of the targeted 300 cats and completion anticipated by 2028.
This first-in-class therapeutic not only provides the first conditionally approved treatment option for subclinical feline HCM but also highlights the need for continued innovation in companion animal health. ‘I am very proud of our team’s achievement in bringing this novel treatment to the hands of veterinarians knowing this will change the lives of cats with this debilitating disease. We will continue our commitment to develop solutions for other unmet needs in our dogs and cats’ said Louise Grubb, TriviumVet CEO.
TriviumVet is an Ireland-based research and development firm dedicated to addressing unmet needs in companion animal health. With a focus on innovative treatments for disease areas often overlooked, such as feline cardiology, TriviumVet collaborates with trusted research partners globally to bring cutting-edge solutions to market. The company is preparing for the U.S. launch of felycin®-CA1 in the summer of 2025. The medication, available by prescription only, is simply administered once weekly, underscoring TriviumVet's commitment to improving the quality of life for cats worldwide.
For more information about TriviumVet and its groundbreaking work in veterinary medicine, please visit www.triviumvet.com.
Important Safety Information about felycin®-CA1
For use in cats only. Pregnant and breastfeeding women should avoid contact with FELYCIN®-CA1. Do not administer FELYCIN®-CA1 in cats with pre-existing liver disease or diabetes mellitus. The most frequently observed adverse reactions in cats treated with felycin®-CA1 were cardiovascular in nature, relating to the progression of HCM.
References
- Luis Fuentes et al. (2020) ACVIM Consensus Statement Guidelines For The Classification, Diagnosis, And Management Of Cardiomyopathies In Cats. Journal of Veterinary Internal Medicine, 34(3), 1062–1077.
- Kaplan et al. (2023) Delayed-Release Rapamycin Halts Progression Of Left Ventricular Hypertrophy In Subclinical Feline Hypertrophic Cardiomyopathy: Results Of The RAPACAT Trial. Journal of the American Veterinary Medical Association, 1–10.