Drug for acute onset of canine pancreatitis is launched on the US market

The first drug conditionally approved by the FDA to treat acute canine pancreatitis (ACP) fuzapladib sodium for injection (Panoquell-CA1; Ceva) is now available in the US. Fuzapladib sodium is a leukocyte function-associated antigen-1 (LFA-1) activation inhibitor that is reasonably expected to block the specific pathway of inflammation associated with acute canine pancreatitis.¹

ACP is a common, and potentially life-threatening, disease. Fuzapladib sodium for injection is indicated for the management of clinical signs associated with acute onset of canine pancreatitis. In the pilot field study for conditional FDA approval, the dogs receiving fuzapladib sodium were shown to have an improved clinical score over dogs receiving symptomatic care alone.¹

“[Fuzapladib sodium for injection] will address an important, unmet medical need for a common, unpredictable disease which has traditionally been managed only with supportive care,” said Susanne Heartsill, DVM, DABVP (canine and feline practice), director of veterinary services at Ceva, in an organizational release.¹ “Panoquell-CA1 is a welcome and valuable product to support recovery and its unique mechanism of action is an incredibly exciting innovation in veterinary medicine.”

ACP is more common in certain breeds and may become a recurring or chronic condition, according to the FDA. "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 an agency news release.² "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."

Dosage administration of this fuzapladib sodium therapy is by intravenous injection at 0.4 mg/kg 1x daily for 3 days and may be given with other types of supportive care. This therapy should not be administered to dogs with a known hypersensitivity to fuzapladib sodium. Furthermore, the safe use of fuzapladib sodium by injection has not been evaluated in dogs with cardiac disease, hepatic failure, or renal impairment as well as those that are pregnant, lactating, or intended for breeding; and canines younger than age 6 months, according to Ceva.¹

The FDA advises veterinarians to explain the possible adverse effects to pet owners. These include loss of appetite, digestive tract disorders, respiratory tract disorders, liver disease, and jaundice.²

Developed by Ishihara Sangyo Kaisha LTD (ISK) and registered by ISK Animal Health, LLC in the US, the product will be marketed and distributed in the US by Ceva Animal Health, LLC. “Fuzapladib sodium has been approved for acute canine pancreatitis in Japan since 2018. Based on our experience in Japan, we believe Panoquell-CA1 will be an important addition to ACP management in the US,” said Yuya Noshiro, director of planning and administration division at ISK Animal Health, in the organizational release.¹

References

1. Panoquell-CA1, the first and only drug conditionally approved by the FDA for management of the symptoms associated with acute onset of canine pancreatitis is now available in the U.S. News release. May 16, 2023. Accessed May 23, 2023. https://www.ceva.us/News-Media/News-Releases-Articles-About-Ceva/PANOQUELL-R-CA1-fuzapladib-sodium-for-injection-is-now-available-in-the-U.S
2. FDA conditionally approves Panoquell-CA1 for acute onset of canine pancreatitis. dvm360. November 22, 2023. Accessed May 23, 2023. https://www.dvm360.com/view/fda-conditionally-approves-panoquell-ca1-for-acute-onset-of-canine-pancreatitis