TriviumVet’s felycin®-CA1 has been granted conditional approval by the United States Food and Drug Administration (FDA), marking a significant milestone in feline cardiac care.
This is the first-ever approval for a feline cardiology drug and the first product approved specifically for use in cats with feline hypertrophic cardiomyopathy (HCM) for any indication.
Felycin®-CA1 (sirolimus delayed-release tablets), administered once weekly, is indicated for managing ventricular hypertrophy in cats with subclinical hypertrophic cardiomyopathy.
“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,” explained Stuart Fitzgerald, Chief Scientific Officer at TriviumVet.
Understanding feline hypertrophic cardiomyopathy
Hypertrophic cardiomyopathy is the most common heart disease in cats and one of the leading causes of feline mortality.
Until now, there have been no FDA-approved treatments available for feline hypertrophic cardiomyopathy, leaving veterinarians and pet owners with limited options.
With this approval, a much-needed management solution for subclinical HCM is now within reach, offering new hope for affected cats.
Prevalence and impact of feline HCM
Feline hypertrophic cardiomyopathy is extremely common, affecting approximately 1 in 7 pet cats. In cats aged 9 years and older, the prevalence rises to approximately 1 in 32, making it a leading cause of mortality in adult cats.
HCM is characterised by abnormal thickening and impaired function of the ventricular wall of the heart. While some cats remain asymptomatic, nearly 50% progress to congestive heart failure or other severe complications.
Subclinical HCM refers to cases where ventricular wall thickening is present, but clinical signs have not yet developed.
How felycin®-CA1 works
Felycin®-CA1 features a species-specific delayed-release formulation designed to target the subclinical phase of the disease before heart failure develops.
It has been shown to reduce ventricular wall thickening (hypertrophy), which is a hallmark of subclinical HCM.
Administered orally once weekly, felycin®-CA1 is set to revolutionise feline hypertrophic cardiomyopathy treatment.
Commitment to ongoing research
An animal drug is eligible for conditional FDA approval if it addresses a serious or life-threatening disease or meets an unmet medical need.
Felycin®-CA1 met these criteria because subclinical HCM often progresses to clinical HCM, which can significantly impact a cat’s quality of life and may be fatal.
To further validate its efficacy, TriviumVet is conducting the HALT HCM Study, a pivotal clinical trial involving over 20 investigator sites across the United States.
The study aims to further demonstrate the effectiveness of felycin®-CA1 in managing ventricular hypertrophy in cats with subclinical HCM.
The HALT HCM Study is progressing ahead of schedule, with enrollment currently nearing 50% of the targeted 300 cats. Completion is anticipated by 2028.
TriviumVet is preparing for the US launch of felycin®-CA1 in the summer of 2025.
Important felycin®-CA1 safety information
- For use in cats only.
- Pregnant and breastfeeding women should avoid contact with felycin®-CA1.
- Do not administer 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.
“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
This breakthrough FDA approval paves the way for better management of feline hypertrophic cardiomyopathy, offering hope for countless cats and their owners. As research progresses, felycin®-CA1 represents a major step forward in feline cardiology.
References
- https://www.fda.gov/animal-veterinary/cvm-updates/fda-conditionally-approves-drug-management-ventricular-hypertrophy-cats
- 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.
