Business
Jaguar Health Issues Regulatory Update Regarding Potential Indication for Crofelemer in Dogs
Company’s Legacy Animal Health Business Supports Focus on Human Health BenefitsSAN FRANCISCO, CA / ACCESSWIRE / August 26, 2019 / Jaguar Health, Inc.
About this update from Jaguar Health, Inc.
[{"type":"text","content":"Company’s Legacy Animal Health Business Supports Focus on Human Health BenefitsSAN FRANCISCO, CA / ACCESSWIRE / August 26, 2019 / Jaguar Health, Inc. (NASDAQ:JAGX) (“Jaguar” or the “Company”) announced today that the Company is scheduled to meet with the U.S. Food & Drug Administration’s Center for Veterinary Medicine (CVM) on September 11, 2019 to conduct a pre-submission conference about the Company’s plans to evaluate crofelemer for exercise-induced diarrhea (EID) in dogs. To expedite the submission and application process for the EID indication, Jaguar will be leveraging use of the same four major technical sections for EID that have been or will be submitted in support of the Company’s application for crofelemer delayed-release tablets (Canalevia™) for the indication of chemotherapy-induced diarrhea (CID) in dogs, which is proceeding on a parallel development path in support of conditional approval.As announced June 19, 2019, the Target Animal Safety technical section, which is the last of the four technical sections Jaguar is required to file for the proposed CID indication, is expected to be submitted to CVM in the third quarter of 2019. “We believe dog experience, such as the recent crofelemer study in dogs with an FDA-approved human tyrosine kinase inhibitor (TKI), is predictive of the expected benefit of crofelemer in human patients suffering from cancer therapy-related diarrhea. With receipt of conditional approval for CID, the Company expects the product to be commercially available for this indication in dogs in the first half of 2020,” Lisa Conte, Jaguar’s president and CEO, stated.EID is a common problem among working dogs, such as sled dogs and military dogs, when subjected to periods of intense, long-duration off-leash exercise. “Elite athletes of all species tend to have more diarrhea than their healthy but more sedentary counterparts, and while the episodes of diarrhea may not be life-threatening, they are nevertheless significant if the goal is peak physical performance. Thus, there is a considerable need in the world of working dogs for products that can reduce the incidence and severity of exercise-induced diarrhea without affecting performance,” commented Dr. Michael Davis, DVM, Ph.D., DACVIM, DACVSMR, a veterinary physiologist and board-certified specialist in veterinary internal medicine and veterinary s...