FDA conditionally approves Panoquell-CA1 for acute onset of canine pancreatitis
First drug approved for the management of acute onset of canine pancreatitis
Today, the US Food and Drug Administration (FDA) conditionally approved Panoquell-CA1 (fuzapladib sodium for injection) for the management of clinical signs associated with acute onset of pancreatitis in dogs. According to the FDA announcement,1 Panoquell-CA1 is an injectable drug intended for use while the dog is hospitalized for treatment of the disease.
Pancreatitis is a painful inflammatory disease of the pancreas that can be life-threatening and generally requires dogs to be hospitalized for treatment. In most cases, it occurs spontaneously. Common factors that increase the chance of developing pancreatitis include1:
- when dogs eat something outside of their normal diet (particularly fatty foods),
- treatment with certain medications,
- and diseases like diabetes mellitus.
According to the FDA, it is more common in certain breeds and may become a recurring or chronic condition.
"This is the first drug to address a serious and life-threatening disease that previously could only be managed through supportive care, such as intravenous fluids, pain medication, anti-emetics, and dietary rest," said Steven M. Solomon, DVM, MPH, director of the FDA's Center for Veterinary Medicine, in the release. "The conditional approval pathway allows medications like Panoquell-CA1 to reach the marketplace more quickly, and in this case gives dogs suffering from acute onset of pancreatitis earlier access to a drug to manage this disease."1
Conditional approval of the drug means that, when used according to the label, the drug is safe and has a reasonable expectation of effectiveness. The initial conditional approval is valid for 1 year with the potential for 4 annual renewals. During this time, the animal drug sponsor must demonstrate active progress toward proving substantial evidence of effectiveness for full approval. If the sponsor does not meet the requirements for substantial evidence of effectiveness at the conclusion of 5 years, the product can no longer be marketed.1
The FDA advises veterinarians to explain the possible side effects to pet owners, which include1:
- loss of appetite
- digestive tract disorders
- respiratory tract disorders
- liver disease
FDA conditionally approves first drug to manage acute onset of pancreatitis in dogs. News release. US Food and Drug Administration. November 15, 2022. Accessed November 15, 2022. https://www.fda.gov/news-events/press-announcements/fda-conditionally-approves-first-drug-manage-acute-onset-pancreatitis-dogs#:~:text=Today%2C%20the%20U.S.%20Food%20and,for%20treatment%20of%20the%20disease.