FDA Invites Jaguar Health to Expedite Submission of Regulatory Filing for Approval of Canalevia (Crofelemer) to Treat Chemotherapy-induced Diarrhea in Dogs
Canalevia would be first and only FDA-approved plant-based medicine for the more than 50,000 dogs that suffer from diarrhea during chemotherapy
According to current estimates, more than 230,000 dogs in the
The filing consists of the All Other Information (AOI) technical section of Jaguar's application for conditional approval of Canalevia for CID under the Minor Use/Minor Species (MU/MS) section of The Minor Use and Minor Species Animal Health Act of 2004.
"We're very pleased with the request from the CVM to expedite the submission of the AOI section of our application," said Dr.
"Jaguar is now another important step closer to having our first approved medicine for use in animals," said Jaguar president and chief executive officer
In addition to pursuing an indication for CID in dogs, Jaguar is also seeking conditional approval to market Canalevia for exercise-induced diarrhea (EID) in dogs. "We expect that Canalevia could be available under conditional approval to treat both CID and EID in the first half of 2021," said
Jaguar's wholly owned subsidiary,
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 filing of the Labeling technical section of the Company's application for conditional approval of Canalevia for CID will occur by the end of