Jaguar Animal Health submit Investigational New Animal Drug Application (INAD) to USFDA for insuling-resistance & metabolic syndromes in dogs

Jaguar Animal Health, an animal health company focussed on developing and commercialising first-in-class gastrointestinal and other proprietary health products for companion and production animals, has submitted its eighth Investigational New Animal Drug application (INAD) with the Center for Veterinary Medicine (CVM) of the US Food and Drug Administration (US FDA) for the treatment of insulin-resistance and metabolic syndrome in dogs. To begin development of a drug for animal use, a company must first file an INAD with the CVM and schedule discussions with the CVM to determine the types of studies that will be used to support safety, effectiveness and manufacturing. 

The most recent drug candidate in Jaguar’s pipeline is being developed for the treatment of obesity-related metabolic dysfunction in dogs, which manifests in altered lipid profiles, insulin resistance and mild hypertension. These metabolic disturbances affect the health of the dogs and could decrease their lifespan. According to a 2012 national survey of veterinarians, approximately 21 per cent of dogs in the US are obese. Obesity is more common in elderly dogs, as well as in neutered dogs.

Jaguar’s chief veterinary officer, Serge Martinod, DVM, Ph.D., commented, “Insulin resistance and metabolic syndrome occurs not just in humans, but also in dogs. However, while physicians worldwide have a vast array of drugs that have been approved to treat this condition in humans, veterinarians have no approved products available to treat these issues in dogs.”

The new prescription drug candidate is isolated and purified from a plant indigenous to the southwestern United States. In traditional medicine, the plant was brewed as a tea and used for the treatment of diabetes and other various illnesses. The prescription drug candidate has been previously evaluated in phase 2 studies in humans, and is also the subject of INADs previously filed by Jaguar for the treatment of type II diabetes in cats and metabolic syndrome in horses.

2 comments:

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