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FDA grants emergency use authorization for Zoetis drug to treat screwworm in dogs

Created at 13 Aug · 6:43 PM1 source↑ Market-relevant
IN SHORT

The U.S. Food and Drug Administration has issued an emergency use authorization for Zoetis' Simparica TRIO, a flea and tick medication, to treat New World screwworm infestations in dogs. The authorization addresses a public health threat where no alternatives are available.

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Key Numbers

2020year Simparica TRIO was approved for other indications

Who's Involved

U.S. Food and Drug Administration
issued emergency use authorization for Zoetis' drug
Zoetis
received emergency use authorization for its drug Simparica TRIO
Elanco Animal Health
also received emergency use nod for its drug Credelio
FDA grants emergency use authorization for Zoetis drug to treat screwworm in dogs

↳ Why This Matters

This emergency authorization provides a new treatment option for dogs affected by the New World screwworm, a potentially serious parasitic infestation, addressing a public health concern in specific U.S. regions.

Key facts

  • The FDA issued an emergency use authorization for Zoetis' Simparica TRIO to treat New World screwworm infestations in dogs.
  • The authorization is for situations where no alternative treatments are available during public health threats.
  • Screwworm infestations have been identified in specific areas of Texas and New Mexico.
  • Dogs in or traveling to affected areas should be monitored for signs of infestation.
  • Simparica TRIO was originally approved in 2020 for heartworm, flea, and tick indications.

The U.S. Food and Drug Administration (FDA) has granted an emergency use authorization for Zoetis' Simparica TRIO, a prescription medication primarily used for heartworm, flea, and tick prevention in dogs. This authorization allows for its use in treating New World screwworm (NWS) infestations in dogs and puppies.

The FDA issues such authorizations during public health threats when no alternative treatments are available. Based on the data reviewed, the agency believes Simparica TRIO may be effective for treating NWS infestations. Currently, the risk of NWS exposure for most dogs in the U.S. is low due to geographic location. However, the FDA advises close monitoring for dogs that live in, travel to, or return from areas where screwworm infestations have been identified, including certain countries south of the U.S. border. Signs of infestation can include visible maggots and foul odors from wounds or body openings. NWS has been detected in specific parts of Texas and New Mexico.

Last year, Elanco Animal Health also received an emergency use nod for its drug, Credelio, to treat dogs infected with New World screwworm.

Frequently asked questions

New World screwworm is a flesh-eating livestock pest that can infest dogs and puppies, causing potential health threats.

The FDA issues these authorizations to permit the use of unapproved treatments during public health threats when no alternatives are available.

Screwworm infestations have currently been identified in specific areas of Texas and New Mexico.

No, Simparica TRIO was approved by the FDA in 2020 for heartworm, flea, and tick indications in dogs and puppies.

What Happens Next

01Dogs in affected areas will be monitored for signs of screwworm infestation.
02Veterinarians will prescribe Simparica TRIO for approved screwworm treatment cases.

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Cadence

How It Developed

The FDA issued an emergency use authorization for Zoetis' Simparica TRIO.
The drug is authorized to treat New World screwworm infestations in dogs and puppies.
The FDA noted low risk for most U.S. dogs but advised monitoring for those in affected areas.
Screwworm infestations have been detected in specific areas of Texas and New Mexico.
The FDA issues emergency use authorizations when no alternatives exist for public health threats.
The FDA believes Simparica TRIO may be effective based on available data.
Simparica TRIO was previously approved in 2020 for heartworm, flea, and tick indications.
Elanco Animal Health also received an emergency use nod for its drug Credelio for screwworm treatment.

Sources

T1
Zoetis gets US FDA emergency use nod for treatment for screwworm in dogsReuters

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