FDA approves renewal for canine chemotherapy-induced diarrhea treatment
Canalevia-CA1 is currently the only treatment on the market for treating CID in canine patients.
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Jaguar Health announced that its product, cofelemer delayed-release tablets (Canalevia-CA1; Jaguar Health), received approved renewal from the FDA. This oral tablet that can be given twice a day for home treatment of chemotherapy-induced diarrhea (CID) in canine patients.
"Canalevia-CA1 is an important prescription drug for the veterinary community and the thousands of dogs experiencing CID. 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,” Michael Guy, DVM, MS, PhD, Jaguar's vice president of preclinical and nonclinical studies, said in a news release.1
“As announced, we have reached agreement with the FDA on the design and conduct of a clinical field study of Canalevia-CA1 for full approval of the product," he continued.
Cofelemer delayed-release tablets received conditional approval from the FDA in December 2021 for treating CID in canine patients, meaning the company could promote the drug legally, advertise and sell the animal drug for the labeled use before proving it meets the "substantial evidence" standard of effectiveness for full approval. For companies that receive the conditional approval, they can ask to renew the conditional approval annually for up to 4 years after first receiving the conditional approval, for a total of 5 years of conditional approval. However, companies must show active progress toward proving the “substantial evidence of effectiveness” for full approval. Once the company collected the remaining effectiveness data, they can then apply for the full FDA approval.
Recent studies have found that CID is 1 of the 3 most prevalent adverse effects for canine patients undergoing cancer treatments, meaning managing adverse effects such as CID can be important to help veterinary teams and clients maintain successful cancer treatment.2
"Diarrhea is a highly neglected and unmet medical need in dogs and people undergoing cancer treatment," Lisa Conte, Jaguar's president and CEO, said. "Jaguar is deeply committed to supporting the quality of life of people and animals undergoing cancer treatment."
Read more about Canalevia-CA1 here.
Cofelemer delayed-release tablets are restricted to use by or on the order of a licensed veterinarian and is to be used only as directed. The treatment is currently available for multiple leading veterinary distributors across the United States and the renewal for conditional approval is in effect until December 21, 2025.1
References
- FDA Approves Renewal of Canalevia-CA1, Jaguar Health's Drug for Chemotherapy-Induced Diarrhea in Dogs. News release. Jaguar Health. November 6, 2024. Accessed November 12, 2024. https://jaguarhealth.gcs-web.com/news-releases/news-release-details/fda-approves-renewal-canalevia-ca1-jaguar-healths-drug-0
- Mason SL, Grant IA, Elliott J, Cripps P, Blackwood L. Gastrointestinal toxicity after vincristine or cyclophosphamide administered with or without maropitant in dogs: a prospective randomized controlled study. J Small Anim Pract. 2014;55(8):391-398. doi:10.1111/jsap.12237
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