FDA conditionally approves first drug for acute onset of pancreatitis in dogs

The Food and Drug Administration announced Nov. 15 that it has granted conditional approval of Panoquell-CA1, or fuzapladib sodium for injection, to Ishihara Sangyo Kaisha Ltd. for the management of clinical signs associated with acute onset of pancreatitis in dogs. Panoquell-CA1 is an injectable drug intended for use while the dog is hospitalized for treatment of the disease.

“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 Dr. Steven M. Solomon, director of the FDA Center for Veterinary Medicine, in the announcement. “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.”

Conditional approval also means that, when used according to the label, the drug is safe and has a reasonable expectation of effectiveness. The drug sponsor must meet the requirements for substantial evidence of effectiveness within five years for full approval.

Fuzapladib sodium, the active ingredient in Panoquell, has been approved since 2018 in Japan to improve clinical signs in the acute phase of pancreatitis in dogs. The FDA reviewed data associated with fuzapladib’s use in Japan as part of its assessment of the application for conditional approval.

Among the possible adverse effects are loss of appetite, digestive tract disorders, respiratory tract disorders, liver disease, and jaundice.