Guide on Developing Dog Heartworm Drugs

FDA has issued a draft guidance #276 entitled “Effectiveness of Anthelmintics: Specific Recommendations for Products Proposed for the Prevention of Heartworm Disease in Dogs.” The document is intended for sponsors interested in pursuing approval of new heartworm prevention products for dogs.

The guidance says that the recommended approach to demonstrate effectiveness for heartworm disease prevention products in dogs is for the sponsor to conduct “two laboratory dose confirmation studies and one multi-site field effectiveness study in accordance with the principles outlined in existing International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) guidance documents. Draft GFI #276 provides specific recommendations for the effectiveness evaluation of drugs intended for the prevention of heartworm disease in dogs, including recommendations on how to establish product effectiveness, better assess effectiveness under actual conditions of use and select heartworm isolates used in laboratory studies.”