Compounded Feline Infectious Peritonitis Medication
by Jenny Alonge
Stokes Pharmacy, in partnership with Bova Group, began in June to offer a U.S.-made compounded oral treatment for feline infectious peritonitis (FIP). The medication, GS-441524, has a complicated history, but veterinarians now can effectively manage this once-fatal disease.
Background
In 2018, University of California, Davis, School of Veterinary Medicine researchers with backing from Gilead Sciences published their findings on GS-441524. The study, which involved 10 cats infected with FIP in an in vitro process, demonstrated that all cats exhibited a rapid reversal of disease signs and returned to normal in as little as two weeks after treatment initiation, with no apparent toxicity. In 2019, the same researchers demonstrated that GS-441524 was also an effective treatment for cats affected by naturally occurring FIP.
Despite these promising results, Gilead did not move forward to seek Food and Drug Administration (FDA) approval for GS-441524 and instead prioritized remdesivir, an identical drug to GS-441524 in part of its structural formula with the same pharmacological effect to inhibit the coronavirus. This put a halt to GS-441524 studies on cats.
When the COVID-19 pandemic hit, Gilead scientists changed the course of their studies to evaluate remdesivir’s efficacy on COVID. This left an effective, legal FIP treatment inaccessible, and desperate owners of cats diagnosed with FIP sought treatment on the black market. According to a 2021 survey conducted by Jones, Novicoff, et al, that involved 393 owners who treated their cats for at least 12 weeks with unlicensed GS-441524-like drugs, 88.2% reported noticeable improvement in clinical signs in one week. At the time of the survey, 96.7% of the cats were alive, and 54% considered their cat cured.
Effective black market options are not a long-term solution, because of the lack of veterinary involvement and the potential for compromised drug quality. In addition, the cat owners reported spending an average of $4,920, which is not financially feasible for many.
Stokes Pharmacy
In 2021, the Bova Group, a veterinary pharmaceutical company comprised of Bova Aus and Bova UK, began compounding GS-441524 for veterinarians in Europe, Australia, Canada, and other countries. Stokes Pharmacy partnered with the Bova Group to offer the drug to U.S. veterinarians.
In the official announcement, Nick Bova, Bova’s managing director stated, “The introduction 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. Together with Stokes Pharmacy, we can now help save cats’ lives across the USA who are impacted by this terrible disease.”
Stokes Pharmacy offers GS-441524 as quad-scored, 50 mg tuna-flavored tablets for cats affected by wet and dry FIP, and can also treat those with ocular or neurologic signs. The medication costs $195 for 10 tablets, $325 for 20 tablets, and $546 for 40 tablets. Current recommendations are treatment for 12 weeks for full disease clearance. Dosage depends on the FIP type, with cats with neurologic and/or ocular signs typically requiring a higher dosage.
FDA’s position
In response to the Stokes Pharmacy announcement, the FDA announced in May that the organization would not enforce new animal drug approval requirements for products compounded from GS-441524 when veterinarian-prescribed for a specific cat patient for FIP treatment under the Guidance for Industry (GFI) #256 Compounding Animal Drugs from Bulk Drug Substances conditions. The conditions include:
- A veterinarian or pharmacist compounds the drug in a state-licensed pharmacy or federal facility.
- The drug is compounded in full compliance with state laws and regulations governing drugs, pharmacy, and veterinary medicine.
- All bulk drug substances, inactive ingredients, and finished drug products used in compounding meet the standards set in any applicable United States Pharmacopeia-National Formulary (USP-NF) monograph. They must also comply with other Federal Food, Drug, and Cosmetic Act requirements for drug components.
- The drug is dispensed by either the pharmacy after receipt of a prescription for a specific patient from the veterinarian acting in a valid Veterinary Client Patient Relationship, or the veterinarian to the pet owner.
- The compounded drug is not a copy of a marketed FDA-approved or indexed drug.
GS-441524 is available by veterinary prescription for individual cats. The drug can be sold to hospitals for office use in all states except Arkansas, Maine, Massachusetts, New Mexico, New York, Oregon, Rhode Island, and West Virginia. Veterinarians in a state that doesn’t allow compounded medications for office use can prescribe GS-441524 in a specific patient’s name.
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