Complicated oral FIP treatment is now available

Stokes Pharmacy and Bova Group (Bova) announced an exclusive partnership to offer an oral dewormer treatment in the United States for feline infectious peritonitis (FIP). The drug will treat the once-fatal virus through a compound preparation backed by Bova's drug formula that has been used in clinical research studies globally.

“Enabled by our Bova partnership, Stokes Pharmacy will prepare and sell the only oral formula identical to the Bova formula used in clinical studies across the globe. Our tablets were tested by Bova to meet their exact specifications. We are thrilled to bring this long-awaited treatment to the US and put FIP ​​treatment back in the hands of veterinarians," said Michael Tursi, president of Stoke, in an organizational statement.¹

According to the announcement,¹ the drug formula created by Bova is used by Bova Aus and Bova UK, with exports to other countries with import permits currently in place. Currently, there is no legal access to oral FIP treatment available in the US for veterinarians. Because of this, pet owners have relied on options outside of an FDA-registered pharmacy or manufacturer to obtain treatment for their sick pets. Recognizing this gap in veterinary medicine, Bova vetted leaders within the industry to find the right partner to help bring their formula to the US market and created this partnership with Stokes Pharmacy.

“Introducing FIP products to Australia and then the UK has taken us on a transformative journey. Collaboration with Feline Specialists around the world has fostered the advancement of knowledge and understanding of FIP. At Bova, we have been fortunate to support numerous clinical trials around the world for our unique formulation. This has helped vets gain the confidence to use our formula and bring the treatment of this fatal disease back under their control,” said Nick Bova, managing director of Bova.¹

^"There are so many black market options available out there and their quality is so varied. We wanted a partner who took quality and science as seriously as we do at Bova. Stokes Pharmacy is an impressive organization that prioritizes quality and science. Now, together, we can finally help save the lives of cats across the US who are affected by this terrible disease," he continued.

The FDA's Center for Veterinary Medicine has alerted veterinarians that compounded GS-441524 falls under Guideline for Industry #256 (GFI #256), making it available to be legally prescribed in the US. GS-441524 has been nominated by Stokes Pharmacy for inclusion on the Animal Drug Bulk Substances List in conjunction with GFI Office Use #256 and now has a GFI List spot under consideration. Because of this, the 50 mg tablets of the compounded medicine are acceptable for sale in hospitals for office sale in every state except Arkansas, Maine, Massachusetts, New Mexico, New York, Oregon, Rhode Island and West Virginia . However, according to the release, veterinarians working in a state that does not allow GS-441524 for office use can prescribe the drug on behalf of the patient.¹

"FDA is aware of social media posts suggesting that compounded GS-441524 will be 'legally' available in the United States beginning June 1. The agency reminds pharmacies, veterinarians and pet owners that the drugs Animal formulations of bulk drug substances are unapproved drugs and are not, in fact, legal.However, in GFI #256, the FDA has outlined some conditions under which the agency does not intend to take enforcement action on compounded products for use in animals. ," the FDA said in an organizational release.²

The GS-441524 compound is now available by veterinary prescription to veterinary offices and individual patients in permitted states.

Reference

1. US compounded oral treatment for feline infectious peritonitis is now available. News release. Stokes Pharmacy. May 20, 2024. Accessed June 14, 2024.
2. FDA announces position on use of compound GS-441524 for treatment of FIP. News release. May 10, 2024. Accessed June 14, 2024. https://www.fda.gov/animal-veterinary/cvm-updates/fda-announces-position-use-compounded-gs-441524-treat-fip#:~: text =%20FDA%20is%20aware%20of,not%2C%20in%20fact%2C%20legal