Benzinga | Dec 21, 2021 01:53PM EST

Jaguar Health Confirms Earlier Reports Of FDA Conditional Approval Of Canalevia-CA1

Jaguar Health, Inc. (NASDAQ:JAGX) today announced it received conditional approval to market Canalevia(tm)-CA1 (crofelemer delayed-release tablets), Jaguar's oral plant-based prescription drug for the treatment of chemotherapy-induced diarrhea (CID) in dogs. This is the first and only product indicated for the treatment of chemotherapy-induced diarrhea (CID) in dogs to receive any type of approval from FDA.

According to the American Veterinary Medical Association, approximately 1 in 4 dogs will, at some stage in their life, develop a tumor, and almost 50% of dogs over age 10 will develop cancer.1 According to the National Cancer Institute, which is part of the National Institutes of Health, roughly 6 million new cancer diagnoses are made in dogs each year in the U.S.

Due to the increasing number of chemotherapeutic treatments being adopted by veterinarians and veterinary oncologists, chemotherapy is quickly becoming the most widely used oncology modality in veterinary medicine. Studies have found the incidence of CID to be one of the three most prevalent side effects in dogs undergoing cancer treatment2, and managing side-effects such as diarrhea is imperative to maintain successful cancer treatment. More than half of the U.S. veterinarians who responded to a recent Jaguar-sponsored survey reported that CID interferes with their patient's chemotherapy treatment plan, indicating an unmet need for an effective product for CID.

Canalevia-CA1 will be marketed as a prescription drug product under the company's Jaguar Animal Health tradename. Jaguar will be sharing more details surrounding the commercialization plan for Canalevia-CA1 in early January 2022.

"We are thrilled to be filling a large gap in the canine cancer care field by providing relief to thousands of dogs and pet owners across the country who thankfully can benefit greatly from advances in canine cancer treatments, yet also have to manage the burden of diarrhea as a common side effect," said Lisa Conte, Jaguar's President and CEO and parent of two Jack Russell Terriers. "In a third-party survey of dog and cat owners, the majority of participants (58%) indicated that they believed that the benefits of chemotherapy did not counterbalance the impact of the potentially negative side effects which animals may experience during treatment.3 Canalevia-CA1 provides another option to address the comfort of dogs undergoing chemotherapy and supports the dog's ability to maintain control, which is important for maintaining a comfortable living environment in the family household."