FDA issues first Emergency Use Authorization for Credelio (lotilaner) to prevent New World screwworm in dogs

The FDA has granted an Emergency Use Authorization for Credelio (lotilaner) to prevent New World screwworm in dogs, a precautionary measure supported by APHIS guidance and commentary from Elanco’s Dr. Casey Locklear.

Veterinarian gently inspecting a dog's flank on an exam table in a clinic

Interview With Elanco’s Dr. Casey Locklear (lotilaner) has received the first ever U.S. Food and Drug Administration Emergency Use Authorization to treat New World screwworm (NWS) infestations in dogs and puppies.

The authorization provides a treatment option for dogs and puppies infected with New World screwworm during the declared emergency; officials note the fly is a concern near the US-Mexico border and the EUA ensures a ready treatment if cases occur in US dogs. The U.S. Animal Plant Health and Inspection Service (APHIS) recommends prevention measures to guard against potential NWS infestations. Such measures are described as important for animal health and, indirectly, public and agricultural health, but New World screwworm is primarily an animal parasite and is not typically described as a major zoonotic threat. How Animal Immunization Safeguards Public Health and Livelihoods.

Elanco, the manufacturer of Credelio, said the authorization marks an unprecedented regulatory step, noting it is the first FDA Emergency Use Authorization for an animal drug and the first EUA for New World screwworm treatment in dogs. The parasite of concern is known for its aggressive behavior toward open skin.

“Any break in the skin—from a scratch to a surgical incision—can become an entry point for NWS, due to its aggressive and invasive nature,” said Dr. Casey Locklear, veterinarian and parasiticide lead at Elanco. Furthermore, it is critical for pet owners to be aware of other parasitic threats, such as whipworm, which can infect dogs and may be more common in certain environments such as areas with heavy dog traffic, though specific annual prevalence estimates vary by study and region.

NWS larvae burrow into the flesh of living animals, causing severe tissue damage and even death if left untreated, according to veterinary summaries accompanying the authorization. Preventing or rapidly treating existing wounds is critical to protecting pets from NWS, the company and animal-health officials emphasize.

The Emergency Use Authorization allows veterinarians to use Credelio (lotilaner) to treat infestations caused by New World screwworm larvae (myiasis) in dogs and puppies under the conditions set by the FDA; federal agencies have emphasized preparedness and surveillance for New World screwworm near the US-Mexico border.

Elanco described its role as the product manufacturer providing the treatment now authorized for emergency use. Dr. Locklear, who leads parasiticide efforts at the company, provided the quoted warning about skin breaks that could permit NWS invasion.

Veterinary stakeholders and animal-health agencies have previously highlighted the severe clinical consequences of screwworm infestation when it occurs in susceptible animals, and the authorization is designed to give clinicians and pet owners an additional option for safeguarding dogs during a potential threat period. The cumulative impact of emerging parasitic diseases underscores the importance of effective surveillance and prevention strategies.

The authorization is framed as a preventive measure while NWS remains absent from U.S. detection, aligning regulatory action with APHIS guidance on readiness and prevention. Officials and the manufacturer emphasize wound care and rapid treatment as essential elements of protection against the parasite.

This development was reported by DVM360, which carried the item attributing the authorization and context to veterinary sources and industry commentary.

Federal agencies and veterinary professionals will determine how this treatment authorization is incorporated into broader New World screwworm response plans, but the EUA itself is specifically limited to treatment of NWS infestations in dogs and puppies during the declared emergency.

Source

Original reporting: view the original article.

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