Compounded oral FIP treatment is now available

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The compounded treatment became available by veterinary prescription of individual patients in permitted states on June 1, 2024

Olga/stock.adobe.com

Olga/stock.adobe.com

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

“Made possible by our Bova partnership, Stokes Pharmacy will compound 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 the veterinarians," Michael Tursi, Stoke’s president, in an organizational release.1

According to the release,1 the drug formula created by Bova is used by Bova Aus and Bova UK, with exports to other countries with import permissions currently in place. Currently, there is no legal access to FIP oral treatment available in the US for veterinarians. Because of this, pet owners have relied on options outside of a pharmacy or FDA-registered manufacturer to get 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.

“The introduction of FIP products to Australia and subsequently to the UK has led us on a transformative path. Collaborating with Feline Specialists around the world has propelled the progression of knowledge and comprehension of FIP. At Bova, we have been fortunate enough to support multiple clinical trials around the world on our unique formulation. This has helped give veterinarians confidence in using our formula and bringing the treatment of this fatal disease back under their control,” said Nick Bova, Bova’s managing director.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 cats' lives across the USA who are impacted by this terrible disease," he continued.

“The FDA’s Center for Veterinary Medicine has alerted veterinarians that, while compounded GS-441524 is not legal, the agency does not intend to enforce new animal drug approval requirements for products compounded from GS-441524, when prescribed by a veterinarian for a specific cat patient for the treatment of Feline Infectious Peritonitis under the conditions listed in Guidance for Industry (GFI) #256 Compounding Animal Drugs from Bulk Drug Substances. GS-441524 has been nominated by Stokes Pharmacy to be included on the list of animal drug bulk substances regarding GFI #256 office use and now has a place on the GFI under review list. Because of this, the compounded medication 50 mg tablets are eligible to be sold 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 who work in a state that does not allow GS-441524 for office use can prescribe the drug in the name of the patient.1

“The FDA is aware of social media posts suggesting that compounded GS-441524 will be “legally” available in the United States starting June 1. The agency reminds compounding pharmacies, veterinarians and pet owners that animal drugs compounded from bulk drug substances are unapproved drugs and are not, in fact, legal. However, in GFI #256, the FDA has described certain conditions where the agency does not intend to take enforcement actions for compounded products for use in animals,” FDA shared, in an organizational release.2

Compounded GS-441524 is now available by veterinary prescription for veterinary offices and individual patients in permitted states.

Reference

  1. US-made compounded oral treatment for feline infectious peritonitis now available. News release. Stokes Pharmacy. May 20, 2024. Accessed June 14, 2024.
  2. FDA announces position on use of compounded GS-441524 to treat 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=The%20FDA%20is%20aware%20of,not%2C%20in%20fact%2C%20legal
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