FORT COLLINS, Colo.--(BUSINESS WIRE)--VetDC, Inc., a veterinary cancer therapeutics company, today announced that the Company has completed all required major and minor technical sections for Tanovea™ (rabacfosadine for injection) and filed its administrative New Animal Drug Application (NADA) for conditional approval with the U.S. Food and Drug Administration’s Center for Veterinary Medicine (FDA-CVM).
The administrative NADA submission is the final step required for FDA conditional approval of Tanovea, and an approval decision is anticipated within 60 days. Upon FDA approval, VetDC intends to commence commercialization in early 2017.
“This is an incredibly exciting time for VetDC, as we are now in the home stretch toward introducing the first FDA-approved drug for use in dogs with lymphoma, one of the most common cancers affecting pets today,” stated Steven Roy, VetDC’s President and CEO.
Tanovea™ (rabacfosadine for injection) is a novel small molecule drug designed to preferentially target and attack cancer cells implicated in lymphoma, one of the most common cancers seen in companion animals. In multiple clinical studies in over 300 client-owned dogs with naturally occurring lymphoma, Tanovea has consistently demonstrated robust anti-tumor activity in both naïve and relapsed cases, with a generally well-tolerated safety profile. Tanovea has a rapid onset of action and is being investigated as a convenient, every-three-week treatment for up to five doses, representing a substantial reduction in client visits relative to non-approved, ‘human’ generic multi-agent chemotherapy regimens commonly utilized in dogs with lymphoma.
VetDC has an exclusive North American license from Gilead Sciences to develop and commercialize Tanovea for companion animal cancer.
About VetDC, Inc.
VetDC (www.vetdc.com) is changing the way new cancer medicines are developed for companion animals, leveraging novel advancements from human biotechnology that have demonstrated success in animal studies. VetDC currently has two cancer programs in development, Tanovea for lymphoma and VDC-597 for multiple cancers.