Jaguar Health Receives "Complete" Letter from FDA for Last of Four Major Technical Sections for the Company's Application for Conditional Approval of Canalevia (Crofelemer) for Chemotherapy-Induced Diarrhea (CID) in Dogs
Jaguar planning for launch of Canalevia™ for CID in dogs this December
Canalevia is the first and only oral plant-based prescription drug candidate for CID in dogs
Canalevia (crofelemer delayed-release tablets) is Jaguar's oral plant-based prescription drug candidate for the treatment of CID in dogs.
"All four of the required major technical sections of our application for conditional approval of Canalevia for CID in dogs have now been deemed ‘Complete' by the CVM. Filing of the New Animal Drug Application (NADA) to request conditional approval from the CVM to market Canalevia for this indication will follow our receipt of a ‘Complete' letter for the minor ‘Labeling' technical section of the application. Filing of the NADA is an administrative activity that will result in conditional approval 60 days later, and we are planning for the launch of Canalevia for CID in dogs in
On average, more than 500,000 dogs in the
Due to the increasing number of chemotherapeutic procedures being adopted by general practice veterinarians and veterinary oncologists, chemotherapy is evolving to become the most widely-used oncology treatment modality in veterinary medicine. Moreover, the most prevalent and used targeted chemotherapy, tyrosine kinase inhibitors (TKIs), are widely becoming adopted by small animal practitioners.
There currently are no FDA-approved medications for the symptomatic treatment of CID in dogs.
"Treating CID is important to influence the outcome of a dog's cancer treatment, by allowing them to maintain a therapeutic dose, and to help with patient comfort - as well helping the dog to maintain control, which is important for the home - the rug, couches, and general living environment - for the dog parent and family," said
"In addition to CID in dogs, Jaguar also plans to seek conditional approval from the CVM to market Canalevia for the treatment of exercise-induced diarrhea (EID) in dogs,"
Crofelemer, Canalevia's active ingredient, comes from the Croton lechleri tree, which is responsibly and sustainably harvested in
For more information about Jaguar, please visit https://jaguar.health. For more information about
Certain statements in this press release constitute "forward-looking statements." These include statements regarding Jaguar's expectation that Canalevia could be available under conditional approval for CID in