Jaguar Animal Health seeks FDA MUMS designation to expand canine diarrhea treatment
Jaguar Animal Health has submitted an application to the FDA’s Center for Veterinary Medicine for Minor Use/Minor Species (MUMS) for designation of the company’s drug candidate crofelemer (Canalevia) for the treatment of exercise-induced diarrhea ( EID) in dogs. The oral herbal drug was conditionally approved by the FDA in December 2021 for the treatment of chemotherapy-induced diarrhea (DIC) in dogs.
“MUMS designation is a status similar to ‘orphan drug’ status for human drugs, and it makes the proposed intended use of a MUMS drug eligible for specific incentives supporting product approval or approval conditional,” said Michael Guy, DVM, MS, PhD, Vice President of Preclinical and Nonclinical Studies at Jaguar Health, in a company press release.
Obtaining MUMS designation for crofelemer for EID in dogs entitles the company to apply for federal grants related to development costs and grants Jaguar Animal Health a longer period (7 years) of market exclusivity after the drug’s conditional approval for EID in dogs, according to Guy. Under the brand name Canalevia-CA1, crofelemer previously received MUMS designation for CID in dogs.
“We believe [Crofelemer] also meets the requirements for MUMS designation for our anticipated EID indication in dogs,” Guy said in the release.
Jaguar Animal Health expects conditional FDA approval for crofelemer, under the brand name Canalevia-CA2, for the treatment of EID in dogs in Q4 2022.