Elanco Animal Health Receives Emergency Use Authorization From The FDA For Credelio Cat To Treat New World Screwworm Infestations In Cats

 Elanco Animal Health Incorporated (NYSE:ELAN) today announced it has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for Credelio™ CAT (lotilaner) to treat New World screwworm (NWS) infestations in cats. This authorization represents the first EUA granted by the FDA for New World screwworm treatment in felines.

 

With confirmed cases of New World screwworm detected as close as 70 miles south of the U.S.-Mexico border,iii this EUA ensures veterinarians and pet owners have a ready-now treatment option for cats and kittens should the fly enter the U.S.

"The FDA's swift and thorough evaluation of the scientific evidence showing Credelio CAT's potential effectiveness against New World screwworm in cats is greatly appreciated," said Dr. Ellen de Brabander, Executive Vice President of Innovation and Regulatory Affairs at Elanco. "As a leader in feline health, Elanco is committed to ensuring cats receive complementary innovative solutions to those available to dogs. This historic EUA equips veterinarians and cat owners with a treatment solution and provides reassurance that they're prepared to act quickly if New World screwworm crosses into the U.S."

Elanco's commitment to feline innovation addresses an important gap in companion animal care. Cats have historically had fewer products and treatment options available compared to dogs, and research shows this disparity extends to veterinary visits—with over 90% of dog owners taking their pets to the veterinarian compared to only 40% of cat owners.iv This EUA ensures that cats have a treatment option on par with their canine counterparts when facing this emerging health threat.

The Emergency Use Authorization was based on research evaluating the efficacy of Credelio CAT against Old World screwworm in cats as well as the efficacy of Credelio against New World screwworm in dogs.

Elanco's Credelio franchise has made significant strides in animal health. Last month, Credelio™ (lotilaner) received the first-ever FDA Emergency Use Authorization for treating NWS in dogs, which is the first time ever that the FDA has issued an EUA for an animal drug. Now, with this EUA for Credelio CAT, the franchise demonstrates its comprehensive approach for providing solutions for both dogs and cats for this emerging threat.

Before New World screwworm reaches the United States, veterinarians and pet owners can take proactive steps to prevent wounds that can create ideal conditions for New World screwworm infection. New World screwworm infestations begin when a female New World screwworm fly lays eggs on open wounds or other parts of the body in live, otherwise healthy, warm-blooded animals. According to the Centers for Disease Control, wounds as small as a tick bite may attract a female fly to feed and lay her eggs. One female can lay 200 – 300 eggs at a time and may lay up to 3,000 eggs during her 10- to 30-day lifespan.v Unlike most fly species whose larvae may feed on dead and decaying tissue, New World screwworm larvae burrow into the flesh of living animals, causing severe tissue damage and even death if left untreated.

The U.S. Animal Plant Health and Inspection Service (APHIS) recommends that one way to prevent New World screwworm infestations is to protect pets and livestock from other wound-causing parasites such as flies and ticks.vi

"Given New World screwworm's aggressive and invasive nature, any minor wounds from grooming, scratching, or outdoor activities can serve as an entry point for these parasites," said Dr. Casey Locklear, Texas-based veterinarian and parasiticide lead at Elanco. "It's essential to prevent or quickly address any wounds to keep cats safe from New World screwworm. Year-round flea and tick protection, like Credelio CAT, helps minimize self-inflicted scratching that could create vulnerable sites."