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SB-001 is an **adeno-associated virus (AAV) vector-based gene therapy** developed for veterinary use to treat chronic kidney disease (CKD)-associated anemia in cats[1][3]. Administered via intramuscular injection, SB-001 introduces the gene for feline erythropoietin (EPO), leading to sustained EPO production and consequential stimulation of erythropoiesis (red blood cell production)[3]. Preclinical and pilot studies demonstrate that a single dose results in a significant increase in packed cell volume (PCV) in cats with CKD-related anemia, improving clinical symptoms and reducing the likelihood of euthanasia from disease progression[1][3]. SB-001 represents the first gene therapy to effectively treat an acquired, non-monogenic veterinary disease and is being evaluated for Expanded Conditional Approval by the FDA Center for Veterinary Medicine (CVM)[3].
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