July 23, 2018
“The FDA is committed to ensuring safe and effective animal drugs are available for the wide range of diverse animal species,” said Steven Solomon, D.V.M., director of the FDA’s Center for Veterinary Medicine. “The four grants awarded today will help animal drug developers fulfill needs for often-overlooked species and for uncommon conditions in species where there is a critical need for an approved product.”
The U.S. Food and Drug Administration is awarding four grants totaling $600,000 for research studies to support the development and potential approval or conditional approval of two minor use/minor species (MUMS) drug applications. The grants are for multi-year projects, and depending on available funding and satisfactory progress by the grantees, the FDA plans to award an additional $600,000 in the next fiscal year. Minor species are animal species other than horses, dogs, cats, cattle, swine, turkeys and chickens. A minor use new animal drug is for the prevention, treatment or control of an uncommon disease in a major species.
The FDA has issued four grants to two companies:
- VetDC Inc., the drug sponsor of Tanovea CA1 (rabacfosadine), which received conditional FDA approval in 2017 for the treatment of lymphoma in dogs, was awarded a grant to fund a field study to determine Tanovea CA1’s effectiveness in treating canine lymphoma and to gather additional safety data. The completion of this study is needed for Tanovea CA1 to be eligible for full approval. Prior to Tanovea-CA1’s conditional approval, the only drugs available to treat canine lymphoma were products approved for use in humans.
- Three grants were awarded to NovaEel Inc., for three studies to demonstrate safety and effectiveness of the drug estradiol administered in feed to American eels. NovaEel Inc. is pursing approval of the drug for increased rate of weight gain in American eels fed in recirculating aquaculture systems.
The Minor Use and Minor Species Animal Health Act of 2004 was signed into law on Aug. 2, 2004, and is intended to make more medications legally available to veterinarians and animal owners for the treatment of minor animal species and for minor uses in major animal species. The FDA opens two application periods each year to apply for MUMS grants, which are dependent upon available funding. In order to apply, the drug must be on the MUMS designations list, the grant funding must be used to defray the costs of safety and effectiveness testing expenses associated with the development of the drug and the FDA’s Center for Veterinary Medicine must already have reviewed and accepted the proposed study protocol. The FDA regularly announces funding opportunities and encourages animal drug sponsors interested in obtaining funding for the development of MUMS drugs to apply.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.