Clinical
FDA issues first-ever Emergency Use Authorization for Credelio chewable tablets
The U.S. Food and Drug Administration (FDA) issued Emergency Use Authorization (EUA), a first-ever for an animal drug, for the use of Credelio (lotilaner) chewable tablets for treatment of New World screwworm (NWS) in dogs and puppies.
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In a release from the FDA, the decision to call for the emergency authorization for Credelio came from the decision Health and Human Services Secretary, Robert F. Kennedy Jr. in August that New World screwworm could pose a “potential for a public health emergency.”
According to the release, the possible benefit of treatment with the drug for treating New World screwworm in dogs and puppies outweighs the risks of the product. New World screwworm poses a low risk to canines in the U.S., and an even lower risk to human health. Though, officially eradicated in the U.S. since 1966, the Centers for Disease Control and Prevention (CDC) and the and United States Department of Agriculture (USDA) are monitoring cases in Central America.
Officials with the FDA hinted that more EUAs could happen in the future for products that could help animals affected by New World screwworm.
“The FDA is using EUAs to bolster our nation’s preparedness for NWS,” said Timothy Schell, Ph.D., director of the FDA’s Center for Veterinary Medicine in the written statement put out by the FDA. “We are working expeditiously to review additional product-specific NWS EUA requests for animals that could be affected by NWS, including livestock, companion animals and wildlife.”
The FDA created a fact sheet for veterinarians, which includes the details of the study documenting efficacy of the drug against NWS in a small population of naturally infected dogs in Brazil, can be found here.
Lotilaner, which is the active ingredient in Credelio, belongs to the isoxazoline drug class of antiparasitic, which the FDA points out has been associated with adverse neurologic reactions, such as seizures. Credelio is sponsored by Elanco US Inc., and was originally approved for flea and tick treatment in dogs and puppies in 2018.
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