Merck gets US FDA emergency use nod for treatment of screwworm in dogs

Nov 3 (Reuters) - The US Food and Drug Administration on Tuesday issued an emergency use authorization for Merck's MRK.N Bravecto tablets to treat New World screwworm in dogs and puppies, expanding treatment options to combat the parasite.

Here are more details:

• The agency said most dogs in the US remain at low risk because confirmed cases are limited to a restricted geographic area

• However, dogs living in, traveling to, or returning from affected regions should be monitored for signs of infestation, including visible maggots or foul-smelling wounds, it added

• The FDA said it concluded, based on available scientific evidence, that it is reasonable to believe Bravecto may be effective in treating screwworm infestations and that its potential benefits outweigh its risks when used as authorized

• The FDA issues emergency use authorizations to allow the use of unapproved treatments during public health threats when no alternatives are available

• Bravecto, whose active ingredient is fluralaner, is already approved for certain flea- and tick-related uses in dogs and puppies

• The drug belongs to a class of antiparasitic medicines called isoxazolines, which have been associated with neurological side effects such as muscle tremors, loss of coordination and seizures, the FDA added

• The agency said the drug will remain available only by prescription through a licensed veterinarian

• The FDA issued the authorization to Intervet, Merck's US animal health unit