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Jaguar Health Receives "Complete" Letter from FDA for Last of Four Major Technical Sections for the Company's Application for Conditional Approval of Canalevia (Crofelemer) for Chemotherapy-Induced Diarrhea (CID) in Dogs
Jaguar planning for launch of Canalevia™ for CID in dogs this DecemberCanalevia is the first and only oral plant-based prescription drug candidate for CID in
About this update from Jaguar Health, Inc.
[{"type":"text","content":"Jaguar planning for launch of Canalevia™ for CID in dogs this DecemberCanalevia is the first and only oral plant-based prescription drug candidate for CID in dogsSAN FRANCISCO, CA / ACCESSWIRE / September 23, 2021 / Jaguar Health, Inc. (NASDAQ:JAGX) today announced that it was informed on September 21, 2021 by the FDA's Center for Veterinary Medicine (CVM) that the Target Animal Safety (TAS) technical section of the company's application for conditional approval of Canalevia for chemotherapy-induced diarrhea (CID) under the Minor Use/Minor Species (MUMS) section of The Minor Use and Minor Species Animal Health Act of 2004 has been deemed \"Complete\". The TAS section - the last of the four major technical sections of Jaguar's application - describes testing undertaken to show that a drug candidate is safe for use under the conditions for which the drug will be prescribed following its approval.Canalevia (crofelemer delayed-release tablets) is Jaguar's oral plant-based prescription drug candidate for the treatment of CID in dogs.\"All four of the required major technical sections of our application for conditional approval of Canalevia for CID in dogs have now been deemed ‘Complete' by the CVM. Filing of the New Animal Drug Application (NADA) to request conditional approval from the CVM to market Canalevia for this indication will follow our receipt of a ‘Complete' letter for the minor ‘Labeling' technical section of the application. Filing of the NADA is an administrative activity that will result in conditional approval 60 days later, and we are planning for the launch of Canalevia for CID in dogs in December 2021,\" said Michael Guy, DVM, MS, Ph.D., Jaguar's vice president of preclinical and nonclinical studies.On average, more than 500,000 dogs in the U.S. are diagnosed with cancer each year. For the most part, dogs receive human chemotherapeutic agents during treatment and suffer the same side effects as humans, which means approximately 40% of treated dogs may have their chemotherapy reduced, changed or discontinued due to diarrhea - which can limit the ability of the veterinarian to extract the full benefit of the chemotherapy agent.Due to the increasing number of chemotherapeutic procedures being adopted by general practice veterinarians and veterinary oncologists, chemotherapy is evolving to become the most widely-used o...