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Jaguar Animal Health Seeks MUMS Designation from FDA for Canalevia (Crofelemer) for Treatment of Exercise-induced Diarrhea (EID) in Dogs
In December of 2021, FDA conditionally approved Canalevia™-CA1 for treatment of chemotherapy-induced diarrhea in dogs, and the company expects Canalevia could
About this update from Jaguar Health, Inc.
[{"type":"text","content":"In December of 2021, FDA conditionally approved Canalevia™-CA1 for treatment of chemotherapy-induced diarrhea in dogs, and the company expects Canalevia could receive FDA conditional approval, under the name Canalevia™-CA2, for treatment of EID in dogsSAN FRANCISCO, CA / ACCESSWIRE / February 16, 2022 / Jaguar Health, Inc. (NASDAQ:JAGX), under its Jaguar Animal Health tradename for the veterinary market, today announced that it has submitted a request to the U.S. Food and Drug Administration's Center for Veterinary Medicine for Minor Use/Minor Species (MUMS) designation for the company's oral plant-based drug candidate Canalevia™ (crofelemer) for treatment of exercise-induced diarrhea (EID) 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. Receipt of MUMS designation for Canalevia for EID in dogs would make the company eligible to apply for Federal grants related to development costs, and provide the company with a longer period (seven years) of marketing exclusivity following conditional approval of Canalevia for EID in dogs,\" said Dr. Michael Guy, DVM, MS, Ph.D., Jaguar Health's vice president of preclinical and nonclinical studies. \"Canalevia, under the name Canalevia™-CA1, has received MUMS designation for chemotherapy-induced diarrhea (CID) in dogs, and we believe Canalevia also meets the requirements for MUMS designation for our planned EID indication in dogs.\"Minor Use/Minor Species (MUMS) section of The Minor Use and Minor Species (MUMS) Animal Health Act of 2004MUMS designation is modeled on the orphan-drug designation for human drug development and offers possible financial incentives to encourage MUMS drug development. The purpose of the MUMS Act is to encourage development and availability of animal drugs intended as a minor use in a major species (dogs, cats, cattle, horses, chickens, turkeys, and pigs) to treat diseases which occur infrequently or in limited geographic areas, and to encourage development and availability of animal drugs for use in minor species (defined as all animals other than humans that are not one of the seven major species).In December of 2021, Jaguar Animal Health received conditional approval from the FDA for Can...