- Jaguar Health has completed submission of a New Animal Drug Application to the FDA’s Center for Veterinary Medicine for Canalevia®-CA1.
- The drug is currently marketed under conditional FDA approval for chemotherapy-induced diarrhea (CID) in dogs.
- A pivotal clinical study demonstrated statistically significant improvement in stool consistency after three days of treatment.
- Full FDA approval would convert the product from conditional to full approval for the CID indication.
Jaguar Health announced it has completed submission of a New Animal Drug Application (NADA) to the U.S. Food and Drug Administration’s Center for Veterinary Medicine seeking full approval of Canalevia®-CA1 (crofelemer) for the treatment of chemotherapy-induced diarrhea (CID) in dogs.
Canalevia®-CA1 is currently available under conditional FDA approval. The NADA submission follows completion of the studies required to demonstrate effectiveness for full approval.
Pivotal study met effectiveness endpoint
According to Jaguar, its recently completed pivotal clinical trial showed that dogs receiving Canalevia®-CA1 twice daily at the onset of chemotherapy-induced diarrhea achieved statistically significant improvement in stool quality after three days of treatment.
The company also reported that 77% of participating dog owners considered the treatment effective, while approximately 40% reported complete resolution of their dog’s chemotherapy-induced diarrhea. By comparison, 10.5% of owners whose dogs did not receive treatment reported complete resolution.
The multicenter study was conducted through veterinary oncology clinics across the United States and formed a key component of the FDA submission. Jaguar also included results from a separate study evaluating crofelemer delayed-release tablets in dogs receiving the targeted chemotherapy agent neratinib.
Addressing an unmet need
Chemotherapy-induced diarrhea is among the most common adverse effects experienced by dogs receiving cancer treatment and can interrupt chemotherapy protocols or require supportive care.
Jaguar noted that while diarrhea is one of the most frequent reasons dogs present to veterinary practices, there are currently no fully FDA-approved drugs specifically indicated for the treatment of general non-infectious diarrhea in dogs. Canalevia®-CA1 is not an antibiotic, which the company says may help reduce unnecessary antimicrobial use when managing chemotherapy-related gastrointestinal complications.
According to the American Veterinary Medical Association, approximately one in four dogs will develop cancer during their lifetime, with nearly half of dogs over 10 years of age affected.
Next regulatory step
The FDA’s Center for Veterinary Medicine will now review Jaguar’s New Animal Drug Application to determine whether Canalevia®-CA1 meets the requirements for full approval.
If approved, the decision would transition the product from conditional approval to full FDA approval for the treatment of chemotherapy-induced diarrhea in dogs.
Information sourced from Jaguar Health’s press release.
