Jaguar Health Submits Final Major Regulatory Filing for Approval of Canalevia (Crofelemer) to Treat Exercise-induced Diarrhea in Dogs
Canalevia would be first and only FDA-approved plant-based medicine for working dogs that suffer from diarrhea
Working dogs, including search and rescue, military and sled dogs, often suffer diarrhea as a result of engaging in long periods of intense, off-leash exercise. "Elite athletes of all species tend to have more diarrhea than their healthy but more sedentary counterparts, which can interfere with peak physical performance," said Dr.
"There is a significant need in the world of working dogs for a safe and effective medicine that can reduce the incidence and severity of exercise-induced diarrhea without affecting performance," he said.
In addition to EID, Jaguar is also seeking conditional approval to market Canalevia for chemotherapy-induced diarrhea (CID) in dogs. "We are leveraging many of the same major technical sections from our CID submission for the proposed EID indication," said Dr.
"We're one step closer to introducing our first FDA-approved oral plant-based medicine for animals," said Jaguar president and chief executive officer
"We're also excited about the potential to develop crofelemer to treat cancer therapy-related diarrhea in humans. Dogs undergoing chemotherapy are an important predictive model for crofelemer's mechanism of action in humans experiencing diarrhea as a result of cancer treatment," said Conte.
Jaguar's wholly owned subsidiary,
The filing to support approval of Canalevia to treat EID in dogs consists of the Reasonable Expectation of Effectiveness technical section for Jaguar's application for conditional approval of Canalevia for EID under the Minor Use/Minor Species (MU/MS) section of The Minor Use and Minor Species Animal Health Act of 2004.
As previously announced, the CVM has confirmed the completeness of Jaguar's Reasonable Expectation of Effectiveness technical section for CID under MU/MS, as well as the CMC (Chemistry, Manufacturing and Controls) and Environmental Impact technical sections of the Company's applications for conditional approval of Canalevia for both CID and EID.
Mytesi (crofelemer) is an antidiarrheal indicated for the symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy (ART). Mytesi is not indicated for the treatment of infectious diarrhea. Rule out infectious etiologies of diarrhea before starting Mytesi. If infectious etiologies are not considered, there is a risk that patients with infectious etiologies will not receive the appropriate therapy and their disease may worsen. In clinical studies, the most common adverse reactions occurring at a rate greater than placebo were upper respiratory tract infection (5.7%), bronchitis (3.9%), cough (3.5%), flatulence (3.1%), and increased bilirubin (3.1%).
See full Prescribing Information at Mytesi.com. Crofelemer, the active ingredient in Mytesi, is a botanical (plant-based) drug extracted and purified from the red bark sap of the medicinal Croton lechleri tree in the Amazon Rainforest. Napo has established a sustainable harvesting program for crofelemer to ensure a high degree of quality and ecological integrity.
Certain statements in this press release constitute "forward-looking statements." These include statements regarding the expectation that Canalevia could be available under conditional approval for EID and CID in the first half of 2021. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "aim," "anticipate," "could," "intend," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue" or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar's control. Some of the factors that could affect our actual results are included in the periodic reports on Form 10-K and Form 10-Q that we file with the