FDA conditionally approves chemo-induced diarrhea treatment for dogs
by Katie Pfaff
The U.S. Food and Drug Administration granted conditional approval of a first-of-its-kind drug to alleviate diarrhea brought on during chemotherapy. The prescription therapy, Canalevia-CA1, is for dogs and is administered at home as a delayed-release oral tablet.
"Diarrhea is a common side effect of chemotherapy in dogs, which can be so severe that cancer treatment must be halted. Chemotherapy drugs often have potential side effects, but, unlike in human medicine where patients may be willing to tolerate some discomfort in exchange for a potential cure, the primary purpose of cancer treatment in dogs and other pets is to extend survival without sacrificing the quality of life and comfort," said Steven M. Solomon, DVM, MPH, director of the FDA's Center for Veterinary Medicine. "This new medication provides veterinarians and dog owners with another tool to help control the side effects of chemotherapy for dogs undergoing such treatment."
The therapy’s active ingredient, crofelemer, is based on a human therapy for diarrhea in patients receiving anti-retroviral treatment for HIV/AIDS, and works by restoring the balance in the gastrointestinal system of discharge of water and chloride ions.
Approval was gained via the minor use/minor species pathway and conditional approval as the number of dogs potentially treated with the drug is expected to be small. The number is estimated to be less than 70,000 dogs based on the 1% of U.S. dogs diagnosed with malignant neoplasia annually. Of that percentage, some will experience diarrhea following chemotherapy treatment.
Conditional approval, which grants marketing of the drug for 1 year and the potential for renewal four times, also includes that the therapy has met safety and manufacturing standards and is “reasonably expected” to be effective (based on a 24 dog study which demonstrated 75% of dogs experienced successful treatment). While under conditional approval, it is expected that robust efficacy evidence is being gathered; if approval is not attained during the 5-year conditional period, marketing of the drug ceases.
Comments
Related Articles
Copyright © 2025 - All Rights Reserved
ISSN 2768-198X
List
Add
Please enter a comment