Comment from Lydia Souran
AnonymousSupportIndividual
Summary: The commenter, likely a veterinarian or animal health professional, argues that GS-441524 should be added to the list of bulk drug substances for compounding. They state that because the drug is life-saving for treating feline infectious peritonitis and currently requires time-consuming external sourcing, its inclusion would prevent fatal delays in treatment for nonfood-producing animals.
Currently, there is no FDA approved treatment for feline infectious peritonitis (FIP), a progressive disease that is inevitably fatal without treatment. Antiviral treatment has demonstrated high clinical success rates, notably with GS-441524 the active metabolite of Remdesivir. Studies have shown the therapeutic benefits of GS-441524 treatment through improvement in clinical signs and survival in cats receiving this treatment.
Although use of GS-441524 has been approved by the FDA for use as an antiviral in humans, neither Remdesivir nor GS-441524 are able to be stocked in veterinary hospitals for use. Without direct access to these medications veterinarians rely on external compounding or sourcing, resulting in critical clinical patients experiencing a delay of treatment. Even short delays in treatment can become fatal due to the rapid decline in these patients’ health. GS-441524 is a life-saving drug that should be available to practitioners to prevent harm and death experienced by nonfood-producing animals with this disease. To address this unmet medical need for time-sensitive treatment, the inclusion of GS-441524 on the list of bulk drug substances should be highly considered.