Canine pancreatitis injectable lands U.S. distribution

Panoquell-CA1, which 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, is now available in the U.S., via Ceva Animal Health, LLC.Dogs hospitalized with pancreatitis can now benefit from newly approved treatment.

Panoquell-CA1, which 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, is now available in the U.S., via Ceva Animal Health, LLC. 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.

“Panoquell-CA1 is the first and only drug conditionally approved in the U.S. to address the inflammation associated with acute onset of canine pancreatitis,” says Ceva’s director of veterinary services, Susanne Heartsill, DVM. “It will address an important, unmet medical need for a common, unpredictable disease which has traditionally been managed only with supportive care.”

Developed by Ishihara Sangyo Kaisha, Ltd., (ISK) and registered by ISK Animal Health, LLC, in the U.S. to treat acute canine pancreatitis (ACP), the product received conditional FDA approval in November 2022.

Fuzapladib sodium, the active ingredient in Panoquell-CA1, is a leukocyte function-associated antigen-1 (LFA-1) activation inhibitor which is reasonably expected to block the specific pathway of inflammation associated with acute canine pancreatitis (ACP), Ceva reports. It has been approved in Japan to improve clinical signs of ACP in dogs since 2018.

“Based on our experience in Japan, we believe Panoquell-CA1 will be an important addition to ACP management in the U.S.,” says Yuya Noshiro, director of planning and administration division at ISK Animal Health.

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