The U.S. Congress granted the FDA a limited extension of the conditional approval pathway for certain new veterinary drugs as part of the FDA’s 2018 new approval of the Animal Drug User Fee Act (ADUFA). The conditional approval allows drug sponsors to legally market a product, after it has been demonstrated that the medicinal product is safe, has been manufactured in accordance with strict standards and there is a reasonable expectation of efficacy for the use and the completion of the pivotal clinical studies.
By granting Conditional Approval, CVM recognizes that no veterinary medicinal product for the treatment of feline HCM is currently approved in the United States. HCM is a serious and life-threatening condition that affects around 15% of cats.
Felycin ™ product development
TriviumVet ™ is conducting a clinical trial on its own cats to evaluate the effectiveness of its patented Rapamycin sustained-release formulation (Felycin ™) in the treatment of HCM. Results from previous laboratory animal studies and observed effects in human organ transplant patients suggest that Felycin ™ has the potential to slow or reverse the adverse cardiac remodeling underlying the disease process in HCM. Preclinical research conducted by TriviumVet has shown that repeated administration of Felycin ™ at a multiple of the intended therapeutic dose is well tolerated by healthy cats.
CEO Louise Grubb Comments:
“We are very excited about this positive response from CVM as it paves the way for first conditional and then full approval, potentially accelerating access to the drug for millions of people at risk. We are excited to see the results of our clinical work beginning next year. ” Year and intend to submit our final study report to the CVM as soon as these results are available.
“At TriviumVet, we are committed to developing treatments for unmet clinical needs, and HCM in cats is one of the diseases that urgently needs to be addressed. Interest in this treatment was in ours December 2020 Brakke Animal Health survey of US veterinarians where 80% of respondents would likely prescribe a novel product for their HCM patients. “
Hypertrophic cardiomyopathy
For information on HCM in cats and more details on the TriviumVet Feline HCM Study, please visit the TriviumVet website. https://bit.ly/3zeJXmp
Information about the TriviumVet company:
TriviumVet, a veterinary research and development company based in Co. Waterford, Ireland, develops a range of new veterinary drugs and diagnostics for pets. TriviumVet identifies gaps in available treatments and has developed a groundbreaking and differentiated portfolio that has the potential to change existing standards of care in the pet specialty markets, including cardiology, kidney (CKD), neuropathic pain and gastrointestinal disorders. More information on the TriviumVet pipeline can be found here: https://triviumvet.com/pipeline/.
@triviumvet
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Please contact:
Sarah O’Connor
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SOURCE TriviumVet
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