Jaguar Animal Health, Inc., an animal health company focused on developing and commercializing gastrointestinal products for companion and production animals, has initiated the filing of its first New Animal Drug Application (NADA) with the U.S. Food and Drug Administration (FDA).
The filing was submitted for Jaguar’s Canalevia prescription drug candidate, a proposed minor-use minor-species (MUMS) drug for use in dogs undergoing chemotherapy.
MUMS is an FDA drug designation, similar to the orphan drug designation in humans, which is typically limited to drugs that are used to treat a small number of animals each year.
Receipt of MUMS designation would allow Jaguar to make Canalevia commercially available before collecting all necessary effectiveness data, but only after proving the drug is safe and showing that there is a reasonable expectation of effectiveness.
Canalevia is a canine-specific formulation of crofelemer, an active pharmaceutical ingredient isolated and purified from the Croton lechleri tree. A human-specific formulation of crofelemer, Fulyzaq, was approved by the U.S. FDA in 2012 for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy.