FDA conditionally approves first oral tablet to treat chemotherapy-induced diarrhea in dogs
SPRING SILVER, Md., December 21, 2021 / PRNewswire / – Today, the United States Food and Drug Administration conditionally approved Canalevia-CA1 (crofelemer delayed-release tablets) for the treatment of chemotherapy-induced diarrhea in dogs. It is the first treatment to be approved for this condition.
“Diarrhea is a common side effect of chemotherapy in dogs, which can be so severe that cancer treatment must be stopped. Chemotherapy drugs often have potential side effects, but unlike human medicine where patients may be willing to tolerate some discomfort in exchange for a potential cure, the primary goal of treating cancer in dogs and other animals companion is to prolong survival without sacrificing quality of life and comfort, ” noted Steven M. Salomon, DVM, MPH, director of the FDA Veterinary Medicine Center. “This new drug provides veterinarians and dog owners with another tool to help control the side effects of chemotherapy in dogs undergoing such treatment.”
Canalevia-CA1 is available only by prescription due to the professional veterinary expertise required to properly diagnose the cause of diarrhea and monitor dogs receiving chemotherapy. Canalevia-CA1 is a tablet which is taken by mouth and may be prescribed for treatment at home.
The active ingredient in Canalevia-CA1 is crofelemer, which is approved for use in humans to treat non-infectious diarrhea in adults with HIV / AIDS who are on antiretroviral therapy. In humans, crofelemer works by inhibiting the secretion of chloride and water ions by intestinal epithelial cells, thereby normalizing the gastrointestinal tract. The drug is believed to work the same in dogs.
Canalevia-CA1 received conditional approval via the Minor use / Minor species route, which is an option for drugs intended for minor uses in major species (dogs, cats, horses, cattle, pigs, turkeys and chickens) or for minor species. Canalevia-CA1 qualified for conditional approval because the FDA estimates that only about 1% of dogs in the United States are diagnosed with malignant neoplasia (cancer) per year, and not all treated dogs have chemotherapy-induced diarrhea. Therefore, the agency estimates that the rate of occurrence of chemotherapy-induced diarrhea in dogs in the United States is less than 70,000 dogs, which qualifies it as minor use in a major species.
Conditional approval allows an animal drug sponsor to legally market their product after demonstrating that the drug is safe and manufactured to full approval standards, and that there is a reasonable expectation that the drug will work. The initial conditional approval is valid for one year with the possibility of four annual renewals. During this time, the sponsor of the animal drug must demonstrate active progress towards substantial proof of efficacy for full approval. The sponsor of the animal drug has five years to obtain full approval after receiving conditional approval, otherwise it will no longer be allowed to market.
The reasonable expectation of effectiveness of Canalevia-CA1 was established in a study of 24 dogs (12 treated and 12 controls). A dog was considered successful in therapy if his diarrhea resolved and did not come back during the three-day study. Resolution of diarrhea was defined as a fecal score of one (well-formed stool) or two (loose or very soft, moist stools that do not have a clear pattern). On the third day, 9 of 12 dogs (75%) in the treated group were treatment successes compared to 3 of 12 (25%) dogs in the control group. In addition, diarrhea resolved within 48 hours in 4 of 12 dogs (33%) in the treated group compared to none of the dogs in the control group.
The most common side effects in laboratory and field studies were abnormal feces (loose, watery, mucoid, discolored stools), decreased appetite and activity, and vomiting.
Veterinarians should advise owners of possible side effects before using the drug. The FDA encourages dog owners to work with their veterinary team to report any adverse event or side effect potentially related to the use of any medicine, including Canalevia-CA1.
The FDA has granted conditional approval of Canalevia-CA1 to Jaguar Animal Health.
Media contact: Veronika pfaeffle, 310-301-2576 or Kim difonzo, 240-651-4191
Veterinary and consumer surveys: [email protected], 800-835-4709
The FDA, an agency of the U.S. Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of drugs, vaccines, and other biologicals for human and veterinary use, as well as medical devices. . The agency is also responsible for the safety and security of our country’s food supply, cosmetics, dietary supplements, products that emit electronic radiation, and the regulation of tobacco products.
SOURCE US Food and Drug Administration