Oct 24 (Reuters) - Elanco Animal Health ( ELAN ) 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.