FOR IMMEDIATE RELEASE
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:
About Ceva Animal Health, LLC
- with cardiac disease, hepatic failure, or renal impairment.
- that are pregnant, lactating, or intended for breeding
- less than 6 months of age.
Ceva offers a growing line of products for companion animals. The company’s products for sale in the U.S. include
the VECTRA® and CATEGO® line of parasiticides, the pheromone products THUNDEREASE® and FELIWAY®, DOUXO® dermatology
products, CARDALIS™ and joint support TRP-Tri-COX®. The company’s North American headquarters is in Lenexa, Kansas.
Jody Donohue Mobile: 913.333.6329 Jody.Donohue@ceva.com
About Ishihara Sangyo Kaisha, Ltd
Ishihara Sangyo Kaisha, LTD. (ISK) is a chemical innovation company based in Japan and listed on Tokyo
stock exchange market that develops a wide range of products in the areas of Agrochemical, Environmental
Products, Functional Materials, Health Care Products and Titanium Dioxide Products. For more information on
ISK visit https://www.iskweb.co.jp/eng/
About ISK Animal Health, LLC
ISK Animal Health, LLC is a whole-owned subsidiary of ISK dedicated to registering animal health products in the
United States that target significant unmet needs in the veterinary community.
PANOQUELL is a registered trademark of Ishihara Sangyo Kaisha, Ltd.
All other trademarks are the property of Ceva Santé Animale S.A. or its affiliates.
November 22, 2022 -
PANOQUELL®- CA1, becomes the first and only drug approved by the FDA for acute canine pancreatitis
in the U.S.