GC376, the Primary Component of Anivive's Feline Infectious Peritonitis Drug, Nominated by AVMA and FelineVMA to FDA's List of Bulk Drug Substance for Compounding Office Stock

18.02.25 13:58 Uhr

  • Nomination could expedite GC376 availability for veterinarians
  • Black market FIP treatments shown to be unpredictable and dangerous
  • Other organizations are encouraged to support GC376's nomination

LONG BEACH, Calif., Feb. 18, 2025/PRNewswire/ -- The American Veterinary Medical Association (AVMA) and the Feline Veterinary Medical Association (FelineVMA) have nominated GC376 for inclusion on the FDA's List of Bulk Drug Substances (BDS) for Compounding Office Stock Drugs for Use in Nonfood-Producing Animals. Currently, Anivive is the primary supplier of GC376 BDS. This marks a significant milestone in the fight against FIP, a fatal disease affecting cats worldwide.

Anivive Logo (PRNewsfoto/Anivive Lifesciences Inc.)

"Anivive is thrilled to have the support of both the AVMA and FelineVMA on the nomination of GC376."- Dr. David Bruyette

If the nomination is accepted by the FDA, Anivive would be able to sell GC376 BDS to compounding pharmacies allowing them to make and sell the compounded medicine to veterinarians. This development would greatly improve the availability of FIP treatments, ensuring that more cats receive the care they need in a timely manner.

Due to the lack of FDA-approved treatments for FIP, veterinarians are concerned that desperate pet owners will turn to unregulated antiviral drugs on the black market. A published study1 of unregulated FIP treatments has highlighted the dangers associated with these illicit therapies, which often lack proper testing and quality control. The study found that unregulated "GC376" vials did not contain GC376 at all.  By providing GC376 as an option through compounding, Anivive aims to eliminate the risks associated with black market alternatives and ensure the safety and well-being of pets.

"Anivive is thrilled to have the support of both the AVMA and FelineVMA on the nomination of GC376," said Dr. David Bruyette, Chief Medical Officer of Anivive. "We're committed to innovative solutions to complex problems, and we've determined that this is the quickest path to get a drug into the hands of veterinarians and pet owners while we continue to pursue full FDA approval."

Anivive is also in contact with other professional veterinary groups to support GC376's nomination. If any organizations are interested in supporting this effort, they are encouraged to reach out to Dr. Chad Dodd at pr@anivive.com

To learn more about compounding guidance for veterinarians visit www.AVMA.org/compounding

About Anivive Lifesciences

Anivive Lifesciences is a software-driven pet pharmaceutical company at the forefront of biotechnology, artificial intelligence, and veterinary medicine. Our mission is to transform veterinary healthcare by accelerating the development of novel, affordable treatments for life-threatening diseases in pets. Through our proprietary AI platform, we are pioneering first-in-class therapeutics in Oncology, Antivirals, and Antifungal Vaccines, setting new standards for innovation and excellence in the industry. To learn more, visit anivive.com   

  • Mulligan AJ, Browning ME. Quality assessment and characterization of unregulated antiviral drugs for feline infectious peritonitis: implications for treatment, safety, and efficacy. Am J Vet Res. 2024 Jan 29:1-9.
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    SOURCE Anivive Lifesciences Inc.