FDA renews conditional approval of medication for chemotherapy-induced diarrhea

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Jaguar Health announced that the FDA has renewed the conditional approval of its Crofelemer delayed-release tablets (Canalevia-CA1). The prescription drug product is indicated to treat chemotherapy-induced diarrhea (CID) in canines. The renewal for conditional approval will be in effect until December 21, 2023, and is available from multiple retailers.

"Diarrhea is a highly neglected and unmet medical need in dogs and people undergoing cancer treatment," said Lisa Conte, Jaguar's president and CEO, in an organizational release.¹ "Jaguar is deeply committed to supporting the quality of life of people and animals undergoing cancer treatment."

According to the release, Canalevia-CA1 received its initial conditional approval in December 2021,² allowing them to legally sell the medication before proving it meets the “substantial evidence” standard needed for full approval. Through this conditional approval, Jaguar Health can also promote and advertise the conditionally approved drug for the labeled uses legally.

The conditional approval is only valid for 1 year, but the company can ask for renewal from the FDA for up to 4 more years. The company is also able to market the drug for its labeled use and collect the data still needed for full approval. Once the data is collected, Jaguar will be able to apply for full FDA approval.

"We're very pleased about receiving the conditional approval renewal from the FDA. 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,” said Michael Guy, DVM, MS, PhD, Jaguar's vice president of preclinical and nonclinical studies.¹

“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," Guy added.

Canalevia-CA1 is the first and currently only oral plant-based prescription product that received conditional approval from the FDA to treat canine CID. The product is made of crofelember, an active pharmaceutical ingredient isolated and then purified from the Croton lechleri tree found in the Amazon Rainforest.¹

To learn more about CAnalevia-CA1, check out this recent episode of dvm360 Live! with Sue Ettinger, DVM, DACVIM (oncology).

Reference

1. FDA Approves Renewal of Canalevia-CA1, Jaguar Health’s Drug for Chemotherapy-Induced Diarrhea in Dogs. News release. December 4, 2023. Accessed December 6, 2023. https://jaguarhealth.gcs-web.com/news-releases/news-release-details/fda-approves-renewal-canalevia-ca1-jaguar-healths-drug
2. Novel plant-based drug now available for the treatment of chemotherapy-induced diarrhea in dogs. dvm360.May 2, 2022. Accessed December 6, 2023. https://www.dvm360.com/view/novel-plant-based-drug-now-available-for-the-treatment-of-chemotherapy-induced-diarrhea-in-dogs