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Jaguar Health’s Plant-Based Prescription Drug Crofelemer Granted FDA Conditional
Approval for Chemotherapy-induced Diarrhea in Dogs

By Hannah Bauman

 

On December 21, 2021, San Francisco, California-based pharmaceutical company Jaguar Health announced that it received conditional Canalevia logoapproval from the US Food and Drug Administration (FDA) for Canalevia®-CA1 for the treatment of chemotherapy-induced diarrhea (CID) in dogs. As part of its conditional approval, Canalevia-CA1 has received a Minor Use in a Major Species (MUMS) designation from the FDA. This designation, which is granted once safety is proven in accordance with FDA standards, covers animal drugs for major species, including horses, cats, cattle, pigs, turkeys, and chickens. “Minor use” refers to the FDA’s threshold for the largest number of dogs (currently 70,000) that can be affected by a disease or condition per year. Jaguar Health can begin marketing the plant-based, prescription-only drug while it undergoes further testing to demonstrate the “substantial evidence of effectiveness” required by FDA for a full approval.1 Canalevia-CA1 has been in development for CID in dogs since 2013.

The active ingredient in Canalevia-CA1 is crofelemer, a novel, plant-based medication derived from the red sap of the dragon’s blood tree (Croton lechleri, Euphorbiaceae), which is also called sangre de drago in its native growing area of the northwest Amazon basin. Indigenous peoples in its native area commonly use the clear, red latex, which the tree exudes when the bark is lacerated, as a traditional medicine for conditions including diarrhea, ulcers, wound healing, skin infections, and respiratory problems. To maintain a sustainable supply of dragon’s blood latex, Jaguar Health’s subsidiary Napo Pharmaceuticals works closely with local and Indigenous people in the Peruvian Amazon to responsibly cultivate the trees, harvest the sap, and create long-term, beneficial relationships with their communities.2

Red latex runs out of a laceration in a Croton lechleri tree. It's gnarly.Crofelemer is purified and refined to contain high levels of proanthocyanidins. Napo Pharmaceuticals has a human formulation of crofelemer on the market under the brand name Mytesi® for noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy. Mytesi is the second botanical-derived prescription drug approved by the FDA. According to the company, Canalevia-CA1 is the first product indicated for the treatment of CID in dogs to receive any type of approval from the FDA.1

According to Michael Guy, DVM, PhD, vice president of preclinical and nonclinical studies for Jaguar Health, the traditional knowledge of Indigenous healers helped guide the development of Canalevia-CA1. “Indigenous people of the Amazon Rainforest have used the red bark sap, or latex, to address diarrhea in themselves and their families for many generations, and they also give the latex to their dogs that have diarrhea,” he wrote (email, April 6, 2022). “More recently, the development of crofelemer to treat CID in dogs was driven by an unmet need within the veterinary oncology community for an effective, non-toxic therapy for this indication.” For dogs and their owners, relief of this symptom of chemotherapy can improve quality of life considerably.

In an FDA press release on December 21, 2021, Steven M. Solomon, DVM, MPH, director of the FDA’s Center for Veterinary Medicine, was quoted as saying: “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 quality of life and comfort. This new medication provides veterinarians and dog owners with another tool to help control the side effects of chemotherapy for dogs undergoing such treatment.”3

Guy commented on the importance of the conditional approval: “It was a significant milestone in 2021 for Jaguar Health to gain conditional approval of Canalevia-CA1 to treat CID in dogs, and the company has designated 2022 as its ‘Year of the Dog.’ Canalevia-CA1 is the first animal drug that Jaguar Health has received conditional approval for, and we look forward to the adoption and use of Canalevia-CA1 by veterinary oncologists and general practitioners for their canine cancer patients dealing with CID.”

Currently, Canalevia-CA1 is available in 125 mg tablets that must be swallowed whole. In the future, Jaguar Health plans to formulate a chewable form of Canalevia-CA1 for ease of administration to sick dogs. The company also is seeking a second conditional approval for Canalevia, under the name Canalevia-CA2, to treat exercise-induced diarrhea in dogs. Working dogs, such as herding dogs, sled dogs, and military dogs, can experience diarrhea because of exertion, similar to a condition known as “runner’s diarrhea” in humans.

Guy concluded: “We continue to be grateful to our Indigenous and local community partners with whom we collaborate on the long-term sustainable harvest of Croton lechleri that Canalevia-CA1 is extracted and purified from.”

References

  1. Jaguar Health Announces FDA Conditional Approval of Canalevia-CA1 (Crofelemer), the First and Only Treatment for Chemotherapy-Induced Diarrhea (CID) in Dogs to Receive Any Type of Approval from FDA [press release]. San Francisco, CA: Jaguar Health, Inc.; December 21, 2022.
  2. King S, Martin ML, Fonseca RP, Fonseca MP, Diaz CGL, Valles KG. Sustainable harvesting of dragon’s blood (Croton lechleri) in Peru. HerbalGram. 2020;125:44-57.
  3. FDA Conditionally Approves First Oral Tablet to Treat Chemotherapy-Induced Diarrhea in Dogs [press release]. Rockville, MD: US Food and Drug Administration; December 21, 2021.
References