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.
(May 16, 2023 - Lenexa, Kan.) The first and only drug conditionally approved by the FDA to treat acute canine pancreatitis (ACP) PANOQUELL®-CA1 (fuzapladib sodium for injection) is now available in the U.S.
Developed by ISHIHARA SANGYO KAISHA, LTD. (ISK) and registered by ISK Animal Health, LLC in the US to treat Acute Canine Pancreatitis (ACP), the product will be marketed and distributed in the U.S. by Ceva Animal Health, LLC.
ACP is a common, and potentially life-threatening, disease. PANOQUELL®-CA1 is labeled 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.
“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. It will address an important, unmet medical need for a common, unpredictable disease which has traditionally been managed only with supportive care,” said Dr. Susanne Heartsill, Director of Veterinary Services at Ceva. “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.”
Fuzapladib sodium 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. PANOQUELL®-CA1 may be given with other types of supportive care.
“ISK Animal Health is excited to partner with Ceva Animal Health to bring PANOQUELL®-CA1 to the US market. 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 Mr. Yuya Noshiro, Director of Planning and Administration Division at ISK Animal Health.
Dosage administration is by intravenous injection at 0.4 mg/kg 1x daily for 3 days.* To learn more, contact your Ceva sales rep or distributor of choice. Learn more about the product by visiting CevaConnect.
Do not use in dogs with a known hypersensitivity to fuzapladib sodium.
The safe use of PANOQUELL®-CA1 has not been evaluated in dogs:
- with cardiac disease, hepatic failure, or renal impairment.
- that are pregnant, lactating, or intended for breeding
- less than 6 months of age.