Felycin®-CA1 (Sirolimus Delayed-Release Tablets) is the First and Only Drug FDA Approved for the Management of Ventricular Hypertrophy in Cats with Subclinical Hypertrophic Cardiomyopathy (HCM), A Condition Affecting as Many as One in Seven Cats
PBI-Gordon Companies, Inc. the parent company of TriviumVet, which holds sole conditional approval from the FDA for Felycin®-CA1 (sirolimus delayed-release tablets) sold under the PRN Pharmacal brand of its affiliated company Pegasus, today announced the product is now available via licensed veterinarians nationwide. PBI-Gordon Companies, Inc. confirms that Felycin®-CA1 is the only drug currently legally marketed under conditional approval from the Food and Drug Administration (FDA) for the management HCM in cats.
Felycin®-CA1 is a specifically designed dosage formulation of sirolimus comprising an enteric coated delayed-release technology that results in a specific pharmacokinetic profile to ensure both the safety and effectiveness of Felycin®-CA1 for cats with HCM. The RAPACAT study was conducted to obtain conditional approval, while the HALT study is currently enrolling cats and being conducted to pursue the full new animal drug approval of Felycin®-CA1 for cats with HCM.
“The use of compounded rapamycin (sirolimus) or the human approved version of Rapamune® has not been approved by the FDA for the management of HCM in cats and has the potential to be very dangerous or even life-threatening if used in cats,” said Dr. Heather Davis DVM, PhD, DACVS-LA, Director of Clinical Affairs and Veterinary Services, Pegasus Laboratories, Inc.
Feline HCM is extremely common, affecting 1 in 7 of all pet cats. In cats 9 years of age and older, the prevalence rises to approximately 1 in 3 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.
PBI-Gordon Companies, Inc. President & CEO Steve Clifford, added, “We are very pleased to issue this update to provide both clarity and comfort for pet owners and veterinarians to ensure that cats with asymptomatic ventricular HCM are receiving the one and only FDA-conditionally approved prescription therapy for this condition.”
Felycin®-CA1 is available now through licensed veterinarians nationwide and is set to fundamentally change the HCM treatment landscape – a market severely underserved.
About PBI-Gordon Companies
PBI-Gordon Companies has been in business in the Kansas City metro area since 1947 and is 100 percent employee-owned. It is the parent company to four subsidiaries which develop, manufacture, and market leading products for Turf and Ornamental (PBI-Gordon Corporation), Companion Animal Pharmaceuticals (Pegasus Laboratories & TriviumVet), and Companion Animal Nutritional Supplements and Grooming Supplies (PetAg).
About Pegasus Laboratories
Founded in 1986, Pegasus Laboratories is a pharmaceutical development and manufacturing organization focused on novel products to treat chronic conditions in cats, dogs, and horses. Pegasus provides full-service Contract Development and Manufacturing Organization (CDMO) focusing on the development and manufacturing with full turn-key technical services in an FDA-registered facility that is in compliance with current Good Manufacturing Practices (cGMPs). Pegasus also provides a full portfolio of pharmaceuticals, nutritional therapeutics and supplements, parasite control and surgical and wound care under the PRN® Pharmacal and Sē·Qual™ brands.
About TriviumVet
TriviumVet is an Ireland-based research and development company working with some of the leading veterinarians and therapeutic specialists around the world to address the gaps in disease management by developing innovative new therapeutic solutions for some of the most serious and underserved conditions. Focused on finding effective treatments for unmet needs in cardiology, renal health, pain management, gastroenterology, wellness testing, and age-related diseases.
Source: https://www.pbigordon.com/
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