FDA Approves Renewal of Canalevia-CA1, Jaguar Health’s Drug for Chemotherapy-Induced Diarrhea in Dogs

Canalevia-CA1 is the first and only treatment for chemotherapy-induced diarrhea (CID) in dogs to receive any type of approval from the FDA

Crofelemer, Jaguar's novel, oral plant-based drug sustainably harvested from the Croton lechleri tree, is the active ingredient in Canalevia-CA1

SAN FRANCISCO, CA / ACCESSWIRE / December 4, 2023 / Jaguar Health, Inc. (NASDAQ:JAGX), under its Jaguar Animal Health tradename for the veterinary market, today announced that the U.S. Food and Drug Administration (FDA) has approved renewal of Canalevia-CA1 (crofelemer delayed-release tablets). Canalevia-CA1, the company's conditionally approved prescription drug product for the treatment of chemotherapy-induced diarrhea (CID) in dogs, is available from multiple leading veterinary distributors in the U.S., including Chewy. The renewal for conditional approval is in effect until December 21, 2024.

"We're very pleased about receiving the conditional approval renewal from the FDA," said Dr. Michael Guy, D.V.M., M.S., Ph.D., Jaguar's vice president of preclinical and nonclinical studies. "This extension was granted because we were able to demonstrate that the company is making active progress toward proving ‘substantial evidence of effectiveness' of Canalevia-CA1 for treatment of CID in dogs for full approval, as required. As announced, the company is planning a clinical field study of Canalevia-CA1 to support full approval of the product for the treatment of CID in dogs. Jaguar plans to initiate this study once the company receives the required concurrence from the FDA on the study protocol."

"Diarrhea is a highly neglected and unmet medical need in dogs and people undergoing cancer treatment," said Lisa Conte, Jaguar's president and CEO. "Jaguar is deeply committed to supporting the quality of life of people and animals undergoing cancer treatment."

About Conditional Approval and Full Approval

Canalevia-CA1 initially received conditional approval in December 2021 from the FDA for the treatment of CID in dogs. FDA's conditional approval allows a drug company to legally sell the animal drug before proving it meets the "substantial evidence" standard of effectiveness for full approval. The company can also legally promote and advertise the conditionally approved drug for the labeled uses. The conditional approval is valid for one year. The drug company can ask FDA to renew the conditional approval annually for up to four more years, for a total of five years of conditional approval. To receive a renewal from FDA, the company must show active progress toward proving "substantial evidence of effectiveness" for full approval. During the conditional approval period, the company can legally market the animal drug for the labeled uses while collecting the remaining effectiveness data. After collecting the necessary data, the company then applies to FDA for full approval. FDA reviews the application and, if appropriate, fully approves the drug.