(Reuters) -Elanco Animal Health said on Friday it had received an emergency use authorization from the U.S. Food and Drug Administration for its flea and tick drug to treat dogs infected with a flesh-eating parasite found near the U.S.-Mexico border.
This is the first time the FDA has granted such an authorization for treating New World screwworm, a type of fly whose larvae feed on the living tissue of animals. The parasite can cause severe wounds and even death if not treated quickly.
“When it comes to emerging animal health threats, we need to be proactive, not reactive,” FDA Commissioner Marty Makary said in a statement.
The FDA issues emergency use authorizations to allow the use of unapproved treatments during public health threats when no alternatives are available.
The move follows a determination by the U.S. secretary of health and human services in August that there is significant potential for a public health emergency involving New World screwworm, which could affect national security or the health of U.S. citizens abroad.
The parasite, Cochliomyia hominivorax, was eradicated from the U.S. decades ago but has recently been detected in areas close to the southern border. The FDA’s move comes before any confirmed cases in the United States.
Elanco said a study published in a scientific journal showed that its drug Credelio, when given orally, cleared the parasite in naturally infected dogs within 24 hours. However, the study was small, involving just 11 dogs in Brazil, and lacked a control group.
The FDA’s emergency use of Credelio is temporary and only valid while the threat of screwworm remains.
The drug is already approved in the U.S. to kill fleas and several types of ticks in dogs.
The company warned that Credelio, part of a drug class called isoxazolines, has been linked to side effects such as tremors and seizures in some dogs.
(Reporting by Kamal Choudhury in Bengaluru; Editing by Maju Samuel)
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