Animal health R&D company, TriviumVet, has the received FDA Center for Veterinary Medicine’s approval to move forward within the expanded conditional process for Felycin™, a therapy for feline hypertrophic cardiomyopathy. The pathway allows Trivium to market the drug while pivotal clinical trials are ongoing as the drug has been deemed safe and meets compliant manufacturing standards.
The pathway is also a mechanism to enhance treatment options for diseases which currently have no approved therapies. In the US, there is no approved drug for feline hypertrophic cardiomyopathy, or feline HCM, a disease which is estimated to impact about 15% of cat companions in the country.
"We are very pleased with this positive response from CVM as it establishes a pathway to first conditional and then full approval, potentially expediting access to the drug for millions of at-risk patients,” said Louise Grubb, chief executive officer at TriviumVet. “We are excited to share results of our clinical work early next year and intend to submit our final study report to CVM once these results are available.”
The pivotal trial will study delayed-release Felycin (rapamycin) in cats after laboratory research and use in human patients who received organ transplants indicated improvement in cardiac parameters in patients with HCM.