PANOQUELL®-CA1 is launched in US in partnership with Ceva: the first and only drug approved by the FDA to improve clinical signs in the acute phase of pancreatitis in dogs
ISK’s Healthcare Business Headquarters announces the launch and first commercial sale of PANOQUELL-CA1 (fuzapladib sodium for injection). This product is available to veterinary clinics across the United States. This first in class product is conditionally-approved by the FDA to address canine acute pancreatitis. ISK Healthcare is dedicated to creating products that address significant unmet needs in human and veterinary medicine. PANOQUELL-CA1 is indicated for a potentially fatal condition that traditionally has been addressed through supportive care alone.
ISK has entered into a marketing and distribution alliance with Ceva Santé Animale S.A., a global animal health company based in France. PANOQUELL-CA1 will be distributed in the United States through a companion animal-dedicated field force by Ceva’s U.S. affiliate, Ceva Animal Health, LLC, headquartered in Lenexa, Kansas.
On November14, 2022, the U.S. Food and Drug Administration (FDA) conditionally approved PANOQUELL-CA1 as the first drug in the U.S. for the management of clinical signs associated with acute onset of pancreatitis in dogs. Prior to that, in September 2018, ISK obtained approval in Japan to manufacture and market ISK products containing fuzapladib sodium as the active pharmaceutical ingredient for “improving clinical signs in the acute pancreatitis of dogs” These ISK products have been commercially available at veterinary hospitals in Japan since that time selling under certain trade names, including “Brenda.”
In ISK’s Vision2030, veterinary drugs and related products are targeted to achieve sales of 15 to 20 billion yen and to develop the product line into ISK’s third major industrial category.
(US) ISK Animal Health, LLC
(Japan) Ishihara Sangyo Kaisha, Ltd.