Felycin®-CA1 is the First and Only Drug FDA Conditionally Approved for the Management of Ventricular Hypertrophy in 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.