Panoquell-CA1 has been granted conditional approval from the U.S. Food and Drug Administration (FDA) for the management of clinical signs associated with acute onset of pancreatitis in canines. The product, which contains the active ingredient fuzapladib sodium, is an injectable drug intended for use while a dog is hospitalized.
Pancreatitis is a painful inflammatory disease of the pancreas, which can be life-threatening and generally requires dogs be hospitalized for treatment, FDA reports. While it mostly occurs spontaneously, common factors that increase the chance of dogs developing pancreatitis include consuming foods outside of their normal diet (particularly fatty foods), receiving treatment with certain medications, and diseases, like diabetes mellitus.
Pancreatitis is more common in certain breeds of dogs and, in some cases, 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,” says Steven M. Solomon, DVM, MPH, director of FDA’s Center for Veterinary Medicine.
Panoquell-CA1’s initial conditional approval is valid for one year with the potential for four annual renewals, FDA says. During this time, the drug’s sponsor, Ishihara Sangyo Kaisha, must demonstrate active progress toward proving substantial evidence of effectiveness for full approval. If these requirements are not met at the conclusion of five years, the product can no longer be marketed, FDA reports.
Fuzapladib sodium, the active ingredient in Panoquell-CA1, has been approved in Japan to improve clinical signs in the acute phase of pancreatitis in dogs since 2018. FDA reviewed data associated with fuzapladib’s use in Japan as part of its assessment of the application for conditional approval.
“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,” Dr. Solomon says.
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