The startup drug company Jaguar Animal Health today reported the filing of its first New Animal Drug Application (NADA) with the U.S. Food and Drug Administration. If approved, the drug Canalevia would be used to treat dogs stricken with watery diarrhea during chemotherapy.
Jaguar described Canalevia as a first-in-class anti-secretory agent intended for use in multiple animal species. The NADA filing requests Minor Use/Minor Species (MUMS) status for dogs as the drug undergoes further study.
The limited designation would allow Jaguar to distribute Canalevia “before collecting all necessary effectiveness data, but after proving the drug is safe and showing that there is a reasonable expectation of effectiveness,” the San Francisco company stated.
The decision to pursue MUMS status followed a meeting Oct. 22 between Jaguar and FDA representatives, according to the company.
“[The] approach … will allow us to bring this new tool for management of certain chemotherapy side effects to dogs in need as soon as possible,” Jaguar reported.
Canalevia contains crofelemer, an antidiarrheal found in the Croton lechleri tree and used to treat HIV-associated diarrhea in people.
Jaguar in September launched its first non-prescription product, Neonorm Calf, for the treatment of watery diarrhea, or scours, in preweaned dairy calves.