Benzinga | Sep 23, 2021 08:35AM EDT

Jaguar Health Receives 'Complete' Letter From FDA For Last Of Four Major Technical Sections For Company's Application For Conditional Approval Of Canalevia For Chemotherapy-Induced Diarrhea In Dogs

Jaguar Health, Inc. (NASDAQ:JAGX) today announced that it was informed on September 21, 2021 by the FDA's Center for Veterinary Medicine (CVM) that the Target Animal Safety (TAS) technical section of the company's application for conditional approval of Canalevia for chemotherapy-induced diarrhea (CID) under the Minor Use/Minor Species (MUMS) section of The Minor Use and Minor Species Animal Health Act of 2004 has been deemed "Complete". The TAS section - the last of the four major technical sections of Jaguar's application - describes testing undertaken to show that a drug candidate is safe for use under the conditions for which the drug will be prescribed following its approval.

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 December 2021," said Michael Guy, DVM, MS, Ph.D., Jaguar's vice president of preclinical and nonclinical studies.

On average, more than 500,000 dogs in the U.S. are diagnosed with cancer each year. For the most part, dogs receive human chemotherapeutic agents during treatment and suffer the same side effects as humans, which means approximately 40% of treated dogs may have their chemotherapy reduced, changed or discontinued due to diarrhea - which can limit the ability of the veterinarian to extract the full benefit of the chemotherapy agent.

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 indogs.

"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 Lisa Conte, Jaguar's president and chief executive officer and parent of two Jack Russell Terriers. "This is a year of pandemic dogs, with dog ownership increasing in the U.S. They are important members of the family."

"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," Dr. Guy added. "With a successful NADA for EID in dogs, Canalevia could be available under conditional approval for this additional indication in 2022."

Crofelemer, Canalevia's active ingredient, comes from the Croton lechleri tree, which is responsibly and sustainably harvested in South America.