By Joseph Harvey
March 14, 2017
Jaguar Animal Health is determining whether or not its Canalevia treatment qualifies for another 'minor use' designation.
The San Francisco-based company has submitted a request to the US FDA for a determination on the minor use label. Jaguar's request is per the requirements of the Minor Use and Minor Species Animal Health Act (MUMS Act) for the indication of exercise-induced diarrhea (EID) in dogs.
Lisa Conte, Jaguar's president and chief executive, said: "If we are successful in obtaining MUMS designation for Canalevia for use in dogs with EID, it is our hope that this could lead to access to Canalevia, under conditional approval, for dogs for this indication also within a year."
Canalevia is Jaguar's lead drug product candidate. It is under investigation for various types of diarrhea in dogs. Earlier this year, the firm secured Elanco as a development partner for Canalevia.
Last year, Jaguar revealed final topline results for a multicenter proof-of-concept study of the active ingredient in Canalevia.
Jaguar has previously received MUMS designation for the use of Canalevia in dogs with chemotherapy-induced diarrhea, which it believes will be the first indication available commercially in the coming 12 months.
The purpose of the MUMS Act, which became effective in 2004, is to encourage the development of drugs for major species (dogs, cats, cattle, horses, chickens, turkeys and pigs) to treat diseases which "occur infrequently or in limited geographic areas". The act is also designed to prompt the availability of products for use in minor species.
Jaguar said the number of dogs in the US affected by EID on an annual basis is less than 70,000. This would qualify the product as a minor use per FDA guidelines.
According to Jaguar, EID is a "distinct physiological manifestation that has been recorded in dogs, humans and horses".
Dr Michael Guy, vice president and clinical veterinarian at Jaguar, said: "EID is a common problem among working dogs, such as sled dogs and military dogs, when subjected to periods of intense, long-duration exercise off-leash. Several mammalian species that physically train and run in competitive events can push themselves to extreme physical demands.
"At this highest level of physical exertion, secretory diarrhea is a common result, and the diarrhea can be debilitating enough to require medical attention and removal from competition or training. Diarrhea can have serious consequences for the canine athlete due to their high capacity for metabolic heat generation and reliance on evaporative cooling to dissipate that heat." Reprinted with permission of Animal Pharm News