Medication

A combination oral FIP treatment is now available

Stokes Pharmacy and Bova Group (Bova) have announced an exclusive partnership to provide the United States’ first-of-its-kind oral treatment for feline infectious peritonitis (FIP). The drug will treat the now fatal virus with a combination preparation backed by Bova’s pharmaceutical formula that has been used in clinical research studies around the world.

“Thanks to our Bova partnership, Stokes Pharmacy will synthesize and market the only Bova oral formulation used in clinical trials worldwide. Our tablets have been tested by Bova “We are excited to bring this long-awaited treatment to the US and put the treatment of FIP back into the hands of veterinarians,” said Michael Tursi, president of Stoke, in a statement.1

According to the release,1 the Bova-manufactured drug formula is used by Bova Aus and Bova UK, with imports that have import licenses currently in place. Currently, there is no legal access to oral FIP treatment available in the US for veterinarians. Because of this, pet owners rely on options outside of a pharmacy or FDA-registered manufacturer to find treatment for their sick pets. Realizing this gap in veterinary medicine, Bova looked to industry leaders to find the right partner to help bring their formula to the US market and formed this partnership with Stokes Pharmacy.

“The introduction of FIP products to Australia and later to the UK has set us on a path of change. Collaborating with Feline Professionals around the world has encouraged the advancement of knowledge and understanding of FIP. At Bova, we have been fortunate to supporting many clinical trials around the world on our unique design.This has helped vets to use our formula with confidence and put the treatment of this deadly disease under their control. ,” said Nick Bova, Bova’s CEO.1

There are many black market options available abroad and their quality varies widely. We wanted a partner that takes quality and science as seriously as we do at Bova. Stokes Pharmacy is an amazing organization that puts quality and science first. Now, together, we can finally help save the lives of cats across the USA affected by this terrible disease,” he continued.

The FDA’s Center for Veterinary Medicine is warning veterinarians that, although compounding GS-441524 is illegal, the agency has no plans to enforce new veterinary drug approval requirements for compounded products from GS-441524, are not prescribed by a veterinarian for a particular cat. patient for the treatment of Feline Infectious Peritonitis under the conditions listed in Guideline for Industry (GFI) #256 Compounding Animal Drugs from Bulk Drug Substances. GS-441524 has been selected by Stokes Pharmacy for inclusion in the veterinary drug bulk list for GFI office use #256 and now has a place on the GFI review list. Because of this, the combination medicine 50 mg tablets are suitable for sale in hospitals for over-the-counter sales 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 approve GS-441524 for office use can prescribe the drug on behalf of a patient.1

“The FDA is aware of social media posts indicating that compounded GS-441524 will be ‘legally’ available in the United States beginning June 1. The agency is reminding compounding pharmacies, veterinarians and pet owners that compounded animal drugs are illegal and, in fact, illegal.However, in GFI #256, the FDA has defined certain conditions where the agency does not intend to take enforcement action for products compounded for use in animals,” the FDA shared, in an agency release.2

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

Reference

  1. A US-made oral treatment for feline infectious peritonitis is now available. News release. Stokes Pharmacy. May 20, 2024. Accessed June 14, 2024.
  2. FDA announces status of use of combination 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%20law

#combination #oral #FIP #treatment

Leave a Reply

Your email address will not be published. Required fields are marked *