FDA Grants Renewal for Canalevia-CA1 for Canine Chemotherapy-Induced Diarrhea
Key Insights
The FDA has approved the renewal of Canalevia-CA1 (search) (cofelemer (search) delayed-release tablets) for treating chemotherapy-induced diarrhea (search) (CID) in dogs.
Canalevia-CA1 (search), developed by Jaguar Health, is administered orally twice daily for at-home treatment of CID in canine patients.
The conditional approval is extended until December 21, 2025, contingent upon demonstrating substantial evidence of effectiveness for full approval.
Jaguar Health's Canalevia-CA1 (search) (cofelemer (search) delayed-release tablets) has received an FDA-approved renewal for the treatment of chemotherapy-induced diarrhea (search) (CID) in canine patients. This announcement ensures the continued availability of the oral tablet, designed for twice-daily at-home administration, until December 21, 2025.
Continued Access to Treatment
According to Jaguar Health, the FDA granted the renewal based on the company's active progress toward providing 'substantial evidence of effectiveness' for full approval of Canalevia-CA1 (search) in treating CID in dogs. Michael Guy, DVM, MS, PhD, Jaguar's vice president of preclinical and nonclinical studies, emphasized the drug's importance for the veterinary community and the thousands of dogs affected by CID.
Conditional Approval Pathway
Canalevia-CA1 (search) initially received conditional approval from the FDA in December 2021. This pathway allows companies to legally promote, advertise, and sell animal drugs for their labeled use before meeting the full 'substantial evidence' standard of effectiveness. Companies can renew this conditional approval annually for up to five years, provided they demonstrate ongoing progress toward full approval.
Clinical Significance of CID Treatment
Recent studies indicate that CID is among the most common adverse effects in canine cancer (search) treatments. Effective management of such side effects is crucial for veterinary teams and pet owners to maintain successful cancer treatment regimens. Lisa Conte, Jaguar's president and CEO, highlighted the significant unmet medical need for diarrhea (search) management in both dogs and humans undergoing cancer treatment, underscoring Jaguar's commitment to improving the quality of life for these patients.
Availability and Usage
Canalevia-CA1 (search) is available through multiple leading veterinary distributors across the United States and is restricted to use by or on the order of a licensed veterinarian, strictly following labeled directions. The active ingredient in Canalevia CA-1, crofelemer, is also under investigation in Jaguar's Phase 3 OnTarget trial for cancer (search) therapy-related diarrhea (search) in humans.