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FDA Announces Draft Guidance for Heartworm Disease Prevention Products for Dogs

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Update: On June 25, 2024, the FDA announced the availability of final guidance for industry (GFI) #276 entitled “Effectiveness of Anthelmintics:  Specific Recommendations for Products Proposed for the Prevention of Heartworm Disease in Dogs.” The FDA received eight comment submissions on the draft guidance, and all comments were considered as the guidance was finalized. 

In the final guidance, the FDA clarified the discussion and recommendations related to geographic locations, laboratory dose confirmation studies, and field effectiveness studies. The agency also clarified that the recommendations in this guidance are based on current technology and veterinary epidemiology, including available diagnostic methodologies. Individuals are encouraged to discuss deviations from these recommendations with the FDA, especially as advances in veterinary medicine related to heartworm disease, including disease epidemiology, isolate characterization, or diagnostic testing are identified. The guidance announced in this notice finalizes the draft guidance dated November 30, 2022.

Update, January 19, 2023: The FDA has announced that it is extending the comment period for draft Guidance for Industry (dGFI) #276, “Effectiveness of Anthelmintics: Specific Recommendations for Products Proposed for the Prevention of Heartworm Disease in Dogs,” until May 1, 2023. The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.  

November 29, 2022

Today, the U.S. Food and Drug Administration is issuing draft Guidance for Industry (dGFI) #276 entitled, “Effectiveness of Anthelmintics: Specific Recommendations for Products Proposed for the Prevention of Heartworm Disease in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 The draft guidance is intended for animal drug sponsors interested in pursuing approval of new heartworm prevention products for dogs.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.

The FDA is seeking public comment on dGFI #276 for 60 days from the date of the publication in the Federal Register. The public should submit either electronic or written comments on the draft guidance by January 30, 2023, to ensure that the Agency considers your comments on this draft guidance before it begins work on the final version of the guidance. 

Comments can be submitted electronically via the Federal eRulemaking Portal, or in writing to Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm 1061, Rockville, MD 20852. 

All submissions received must include the Docket No. FDA-2022-D-2899 for “Effectiveness of Anthelmintics: Specific Recommendations for Products Proposed for the Prevention of Heartworm Disease in Dogs.”  

For more information:

Issued by FDA Center for Veterinary Medicine.
For questions, Contact CVM.

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