Jaguar Animal Health seeks MUMS designation from FDA to expand canine diarrhea treatment
Jaguar Animal Health has submitted a request to the FDA’s Center for Veterinary Medicine for Minor Use/Minor Species (MUMS) designation for the company's drug candidate crofelemer (Canalevia) for treatment of exercise-induced diarrhea (EID) in dogs. The oral, plant-based drug was conditionally approved by the FDA in December 2021 for the treatment of chemotherapy-induced diarrhea (CID) 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 conditional approval," said Michael Guy, DVM, MS, PhD, Jaguar Health's vice president of preclinical and nonclinical studies, in a company press release.
Receipt of MUMS designation for crofelemer for EID in dogs provide the company with eligibility to apply for federal grants related to development costs, and allow Jaguar Animal Health with a longer period—7 years—of marketing exclusivity following conditional approval of the drug 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 planned EID indication in dogs," said Guy in the release.
Jaguar Animal Health is anticipating conditional approval from the FDA for crofelemer, under the brand name Canalevia-CA2, for treatment of EID in dogs in the fourth quarter of 2022.
Crofelemer is should only be used by or on the order of licensed veterinarians. The most reported adverse reactions included decreased appetite, decreased activity, dehydration, abdominal pain, and vomiting.
Jaguar Animal Health seeks MUMS designation from FDA for Canalevia (Crofelemer) for treatment of exercise-induced diarrhea (EID) in dogs. News release. Jaguar Animal Health. February 16, 2022. Accessed February 16, 2022. https://jaguarhealth.gcs-web.com/news-releases/news-release-details/jaguar-animal-health-seeks-mums-designation-fda-canalevia