May 14, 2020
As part of the FDA’s continuing mission to assure that safe and effective animal drugs are available to meet the health needs of a wide range of diverse species, the agency has awarded four new grants totaling $615,023 to help fund research to support the approval or conditional approval of new animal drugs intended for minor uses or minor species (MUMS). Two of the grants are for multi-year projects for drugs intended for minor uses. The FDA plans to award an additional $499,623 for these two grants in the next fiscal year, provided that funds are available and the grantees are able to show satisfactory progress. The other two grants are for aquaculture studies.
The four grants will provide funding for studies to support the approval or conditional approval of three different MUMS products, including a cancer drug for dogs. Anivive Lifesciences, Inc. will use the grant award to conduct a field study to determine the effectiveness of verdinexor for the treatment of lymphoma in dogs. The FDA also awarded a grant for Okava Pharmaceuticals, Inc. to conduct an effectiveness study for OKV-1001 for adjunctive therapy for the treatment of newly-diagnosed idiopathic (non-associative) immune-mediated hemolytic anemia (IMHA) in dogs. OKV-1001 is an extended release formulation of mycophenolate sodium.
The FDA awarded two grants to AquaTactics LLC for two studies to demonstrate the effectiveness of sulfadimethoxine and ormetoprim (Romet 30) for the control of mortality due to enteric redmouth disease associated with Yersinia ruckeri in freshwater salmonids. PHARMAQ AS of Norway is the drug sponsor pursuing a supplemental approval of Romet 30 Type A medicated article for this intended use.
The Minor Use and Minor Species Animal Health Act of 2004, commonly referred to as the “MUMS Act,” was signed into law on August 2, 2004. The law is intended to make more medications legally available to veterinarians and animal owners for the treatment of minor animal species (those other than horses, dogs, cats, cattle, pigs, turkeys and chickens), and for uncommon diseases in major animal species, i.e., minor uses.
The MUMS Act provides innovative ways to bring products to market for these underserved animal populations and is designed to help veterinary pharmaceutical companies overcome the financial roadblocks they may face in developing animal drugs for a limited market. Before this legislation, veterinary pharmaceutical companies would rarely attempt to bring such drugs to market.
The FDA opens two application periods each year to apply for MUMS grants, which are dependent upon available funding. To apply, the new animal drug must be on the MUMS designations list for the intended use(s) for which the drug is being studied; the grant funding must be used to defray the costs of qualified safety and effectiveness testing associated with developing the drug; and the FDA’s Center for Veterinary Medicine must have already reviewed and accepted the proposed study protocol.
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Issued by FDA Center for Veterinary Medicine.
For questions, Contact CVM.