FDA announces draft guidance for heartworm disease products
Today, the U.S. Food and Drug Administration is issuing draft Guidance for Industry (dGFI) #276 entitled, “Effectiveness of Anthelmintics: Specific Recommendations for Products Proposed for the Prevention of Heartworm Disease in Dogs.” The draft guidance is intended for animal drug sponsors interested in pursuing approval of new heartworm prevention products for dogs.
Heartworm disease is a serious disease that may result in severe lung disease, heart failure, other organ damage, and death in pets, mainly dogs, cats, and ferrets. It is caused by a parasitic worm called Dirofilaria immitis. The worms are spread through the bite of a mosquito. Preventing heartworm disease is important because treatment for heartworm disease can cause significant adverse effects in dogs and is expensive for pet owners.
On May 24, 2018, the FDA published a Federal Register Notice requesting input on possible alternative approaches for evaluating heartworm disease prevention products for dogs. The FDA asked for public input because of reports of lack of effectiveness and the limitations of the effectiveness studies conducted to support product approval. The FDA considered the comments received in response to the notice in creating dGFI #276.
The recommended approach to demonstrate substantial evidence of 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 Harmonisation 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. The FDA recommends that sponsors also consult related VICH guidance documents, which are intended to provide additional details regarding study types and design.
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